MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTT

FDA device recall Z-0235-2025 · posted 2024-10-29 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Action taken

Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall letter via E-mail and FedEx overnight mail on 9/20/24. Letter states reason for recall, health risk and action to take: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the lot number and total quantity of the affected product that you have. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to FCA1@integralife.com or FAX to 1-609-750-4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities which you returned. PLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT TO RETURN OR NOT A COMPLETED ACKNOWLEDGEMENT IS REQUIRED Additional actions to be Taken by Integra Sales Representatives and/or Distributors: 7. Check your customer traceability records for shipments of above catalog and lot numbers. 8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 9. Distributors can request a credit for the quantities which they returned. Should you have any questions regarding these instructions, please contact your Integra Sales Representative or Customer Service from Monday to Friday 8:00 a.m. 8:00 p.m. EST at 1-800-654-2873 or custsvcnj@integralife.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

HBA

Quantity affected

1791

Distribution

Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgiu

Date initiated

2024-09-20

Date posted

2024-10-29

Location

Princeton, NJ

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