medical Class II Updated 2024-11-06

Integra LifeSciences Corp. recalls SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The s

Recalled Product

SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI# 10381780514930, 20886704036453 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
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