Form e-Form/Link Device Correction/Removal Report

OMB Control Number: 0910-0359
Expiration Date: 10/31/2023

Device Correction/Removal Report for Industry
Paperwork Reduction Act Disclosure Notice

This form is intended to facilitate the reporting requirements of 21 CFR Part 806 concerning corrections or removals of medical devices by industry. Federal collections of
information, including forms, are governed by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and its implementing regulations (5 CFR 1320). Respondents are not
required to complete this form unless a valid OMB Control Number and expiration date are displayed in the upper right hand corner of this form.

[Form Instructions]
To facilitate your recall, we have included the link to our "Recalls, Market Withdrawals &
Safety Alerts" web page. This link is intended to provide guidance and instruction to FDA
regulated industry regarding product recalls: https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts.
21 CFR Part 806 requires manufacturers and importers to notify FDA of certain device
corrections and removals actions. We recommend these be reported to your Division
Recall Coordinator electronically. Please also submit the draft letter and recall strategy
prior to initiation. It is recommended to not wait until all information is completed, but to
submit this information as soon as possible. This "early" notification will allow FDA the
opportunity to review and comment on your written notification and to offer guidance and
assistance in your recall process.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.10
FDA DEVICE RECALL CONTACTS:
When recalling firm (initiating recall) is in: CT, DE, IN, KY, MA, ME, MD, MI, NH, NJ, NY,
OH, PA, RI, VA, VT, WV and the District of Columbia.
[email protected]
When recalling firm (initiating recall) is in: AL, FL, GA, IA, IL, KS, LA, MN, MO, MS, NC,
ND, NE, SC, SD, TN, WI, Puerto Rico, and the US Virgin Islands.
[email protected]
When recalling firm (initiating recall) is in: AK, AR, AZ, CA, CO, HI, ID, MT, NM, NV, OK,
OR, TX, UT, WA and WY.
[email protected]

Firm Information
Recalling Firm
FDA Establishment Identifier (FEI)

Firm Type

Firm Name
Address
City
Telephone

No Dashes (Add International
Phone Number to Comments)

State/Province
Area Code

Postal Code
Number

Country
Ext

Country Code

Comments
If your product is imported into the US please provide the following info below FEI, establishment name, and address.

Importer Information

Top Firm Official / Most Responsible Individual
Official's Name

Title

Firm Name
Address
City
Telephone

No Dashes (Add International
Phone Number to Comments)

State/Province
Area Code

Postal Code
Number

Country
Ext

Country Code

E-mail Address
Comments

Manufacturer
FDA Establishment Identifier (FEI)
Firm Name
Address
City
Telephone No Dashes (Add International
Phone Number to Comments)
E-mail Address
Comments

Area Code

Country

Postal Code

State/Province
Number

Ext

Country Code

Firm Information Cont'd
Additional Manufacturer, if applicable
FDA Establishment Identifier (FEI)
Firm Name
Address
City

Postal Code

State/Province

Telephone

No Dashes (Add International
Phone Number to Comments)

Area Code

Number

Country
Ext

Country Code

E-mail Address
Comments

Recall Contact at Recalling Firm
Official's Name

Title

Firm Name
Address
City

Postal Code

State/Province

Telephone

No Dashes (Add International
Phone Number to Comments)

Area Code

Number

Country
Ext

Country Code

E-mail Address
Comments

Additional Recall Contact at Recalling Firm, if applicable
Official's Name

Title

Firm Name
Address
City
Telephone No Dashes (Add International
Phone Number to Comments)
E-mail Address
Comments

State/Province
Area Code

Postal Code
Number

Country
Ext

Country Code

Firm Information Cont'd
Public Contact
Title

Official's Name
Firm Name
Address
City

State/Province

Telephone

No Dashes (Add International
Phone Number to Comments)

Postal Code
Number

Area Code

Country
Ext

Country Code

E-mail Address
Comments

Event Information

Identify Reason for
Recall

Recall Initiation Date

Firm Awareness Date

Please enter the Minimum and Maximum Manufactured and Distribution Dates below.
Manufactured Dates

From

To

Check if product is still being manufactured.

Distribution Dates

From

To

Check if product is still being distributed.

How was the problem discovered?
If discovery was through testing, please
provide copies of the analysis.

Any reported illness or injury?

Yes

No

If yes, describe the types
of injuries and provide
MDR number.
Did you conduct a Health Hazard Evaluation
(HHE)? If so, please include a copy.

Yes

No

Event Information Cont'd
Provide details if you have
determined a root cause for the
problem.

Number of complaints received (provide copies)
MDR Submitted? (provide copies)
If so, how many: Deaths?

Yes

No
Injuries?

Malfunctions?

Other?

Report of Corrections and Removal number
([Registration # or FEI]/mmddyyyy/RorC/#####)

What criteria did you use
to establish the scope of
the recall?

Distribution Details

Please provide a complete listing of all locations where this product was sent to.
• Please include the following information in Microsoft Excel (each in its own cell): Customer name/ physical address/
city/ state / zip code /telephone (please avoid duplicate consignee locations)
• Please separate foreign and domestic consignees
• Please separate Military and Government consignees
Please fill in the box below as to the number of Government consignees. If no Government consignees indicate None.
Government/ DoD
Addresses / Comments
Please fill in the box below with the Distribution Pattern, such as states and countries the product was distributed too.
Distribution Details

# of Domestic Consignees

# of Foreign Consignees

Please fill in the table below as to the number of each type of consignee, for U.S. only, including Government consignees.
Consignees

Approx. Number

Consignees

Approx. Number

Consignees

Approx. Number

Distributor

Physician

Department of Defense

Retailer

Consumer/Patient

Manufacturer

Institution

Re-packer / Relabeler

USDA

Medical Facility

Direct Accounts

Other

Internet Sales

Veterans Administration

Event Information Cont'd
Recall Strategy
Indicate the customer level to which you are extending the
recall.(i.e. wholesale, hospital, retail, consumer, etc. )
If your recall only extends to the
wholesale/distributor level, please justify.
Indicate the method of notification (i.e. mail, phone, facsimile, e-mail, letter, visit).
Indicate the date the notification was was first issued. It is advisable to include a written notification,
so customer will have a record of the recall and your instructions.
If letters will be sent, indicate how letters will be sent to customers (e.g. overnight
mail, first class mail, certified mail, facsimile), and whether a third-party recall
company is being used (provide name and address of third party)
Indicate the date you notified specific consignees, if different from the notification date.
Instructions:
• If initial notification is by phone, you must provide a copy of the phone script to FDA and the date(s) that notification
was attempted and/or achieved.
• If you have a web site, you should consider posting the recall notifications on the web site as an additional method of
recall notification. (Note: This is not recommended as a sole means of customer notification.)
• Please attach a copy of your customer notification.

Report on what you have instructed
customers to do with the recalled product.

How are you determining if the recall is
effective? What effectiveness checks are
you conducting?

NOTE: Effectiveness checks are your means of evaluating the effectiveness of your recall. If your effectiveness checks indicate that the recall
notification was not received, read and/or instructions followed, then you should take necessary steps to make the recall effective. These
steps may involve sending out a follow up notification that better identifies the product, better explains the problem and/or provides better
instructions to customers.

How are you planning on following up with
customers who do not respond?

Determine and provide your course of action
for out-of-business distributors.

If the product is to be "reconditioned" or
corrected, provide details of the reconditioning or
correction plan and seek concurrence by your
FDA Recall Coordinator prior to implementation.

Event Information Cont'd

What are you planning to do with
any returned product?

How are you going to store it?

What is the destruction plan?
Provide the details (date, method,
and location) prior to destruction in
the event FDA would like to
witness the action.

What preventative measures have
you taken or are planning to take
to prevent this event from
occurring again? Please provide a
copy of the final CAPA

Press Releases
• In a situation where the product may pose a significant health hazard and recalled product is in the hands of
consumers, a press release is usually appropriate.
• If a press release was issued or will be issued, please submit a copy.
• Issuance of a press release should be the highest priority and it should be issued promptly.
• Unique situations will be handled on a case-by-case basis.
*You should consult with your respective Recall Coordinator before issuance of a press release whenever possible.
*Submit press release to an appropriate newswire that will reach all intended consumers.
**For example: The AP- send the press release in the body of an email (no attachments) to [email protected]
NOTE: For those recalls where FDA believes a Press Release is warranted, the Agency may issue a Press Release if the firm
has failed to do so, or if the firm-initiated press release is not adequate.

If not issuing press release,
please submit justification.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format) as well as product inserts and any information
sheets for all products being recalled.
Product Code Builder
Product 1 (additional products can be entered at the end of this document)
Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 2

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

Is product controlled by software?

No
Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 3

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

Is product controlled by software?

No
Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 4

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

Is product controlled by software?

No
Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 5

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

Is product controlled by software?

No
Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 6

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined
-

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 7

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 8

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 9

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 10

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 11

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 12

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being manufactured.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 13

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 14

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 15

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 16

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 17

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 18

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 19

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.

Product Information
Include a complete copy of all labeling (preferably in color and .jpeg format). Include product inserts and any information sheets
for all products being recalled.

Product 20

Industry Code

Product Code

Brand Name
Product Name
Model/ Catalog Number
Software version, if applicable
For Product Description please include common name and/or general use category (ie. Cardiac catheter, urinary catheter), volume,
packaging, etc.

Product
Description

Is it a component? If so, what is it a component of?
For Product Identifying Codes please include all applicable elements: UDI, GTIN, Lot Numbers, Serial Numbers, Software Revisions,
Expiration Date. Whatever distinguishes the recalled product from product that is good. If you say, “all lots,” differentiate the recalled product
from future production (all lots up to ### or date). Please format in the following manner: Model No XXXXX; UDI-DI XXXXXXXX; Lot
Numbers/Serial Numbers 0000000, 1111111, etc.

Product
Identifying
Code(s)

Shelf Life

Expected Life
Indication of Use
510K/PMA Number
Is product sterile?

Yes

No

Is product controlled by software?

Yes

No

Is this a tracked device?

Yes

No

Is this an implantable device?

Yes

No

Total Quantity Manufactured (eaches only)
Manufactured Dates

From

To

Check if product is still being manufactured.

Product Quantity Distributed (eaches only)
Distribution Dates

From

Amount of Product Quarantined

To

Check if product is still being distributed.