Integra LifeSciences Corp. recalls MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COT…

Recall date

September 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0235-2025

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (the…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.