Reported Nov 6, 2024 · Ongoing
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- SURG
- PAT XRAY 1/4X1-1/2 Model/Catalog Number801397. 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
- Lot codes and dates
- Lot Code
UDI# 1038178051493020886704036453
- Notethe 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
- Lot Code
- Amount recalled
- 2615
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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