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FDASeptember 20, 2024device

SURG PAT XRAY 1X1 Model/Catalog Number: 801403. 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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

integra lifesciencesintegra

UPCs

1038178051499220886704036514

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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SURG PAT XRAY 1X1 Model/Catalog Number: 801403. 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. — Recall Details · AllClear