Integra LifeSciences recalls Codman Surgical Patties (part 801400, lot 6396457) due to possible minor fever from endotoxin issues. Affected units may cause temporary fever during surgery.
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Integra LifeSciences is recalling Codman Surgical Patties with a specific lot number because they may contain endotoxins that could cause a minor fever during surgery. This is a small risk that doesn't require immediate action but should be checked.
The recalled patties had endotoxin levels outside acceptable specifications. This could lead to a minor, temporary fever during surgery, but not serious injury or death.
Surgical teams using the affected lot of Codman Surgical Patties (part 801400, lot 6396457) are most at risk. Patients undergoing surgery with these patties may experience a temporary fever.
Check for the part number 801400 and lot number 6396457 on the packaging. The expiration date is June 30, 2027.
Look for the part number 801400 and lot number 6396457 on the packaging.
The recall is for a potential minor fever risk during surgery, not serious injury or death.
Check the product details to see if it matches the recalled lot number. If it does, contact Integra LifeSciences for guidance.
Look for the part number 801400 and lot number 6396457 on the packaging. The expiration date is June 30, 2027.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0909-2023 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0909-2023 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
