Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging defects that could compromise sterility. Affected units have specific lot numbers and expiration dates.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Integra LifeSciences is recalling cranial access kits without prep solutions because their sterile packaging might not be intact, risking contamination during medical procedures. This could lead to infections or other complications if the kit is used improperly.
The sterile packaging for the cranial access kit may not hold its integrity, which could allow contamination. This defect might compromise the sterility of the kit during medical procedures, potentially leading to infections.
Medical professionals using the cranial access kits for brain surgery or procedures are most at risk. Patients receiving these kits during surgery could be affected if the packaging fails.
Check for the product name 'Integra Cranial access kit (without Prep solutions) Bit and Guard'. Look for lot numbers like 10381780263975, 6710227, 6788602, etc., and expiration dates from June 2024 to May 2025.
Review the lot number and expiration date on the packaging to confirm if the item is affected.
The sterile packaging may not hold its integrity, which could compromise the sterility of the kit during medical procedures.
The recall does not specify a remedy, so check the product details to see if it is affected and contact Integra LifeSciences for further instructions.
Yes, affected units include lot numbers like 10381780263975, 6710227, 6788602, 6955170, 7000268, 7028247, 7078234, 7249010, and 7253163.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1202-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1202-2024 from Integra. 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.
