Integra LifeSciences recalls Cranial Access Kits with defective sterile packaging that may compromise product sterility. Affected kits have specific lot numbers and expiration dates. Consumers should contact Integra for details.
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 that may have defective sterile packaging. This could lead to contamination if the kit is used in medical procedures. The recall affects specific lot numbers with expiration dates from September 2023 to June 2024.
The sterile packaging for the Cranial Access Kit failed integrity testing, which could mean the kit is not sterile when opened. If used in medical procedures, this might lead to infection or contamination.
Medical professionals using the Cranial Access Kit for brain procedures are most at risk. The recall applies to kits with specific lot numbers and expiration dates from September 2023 through June 2024.
Check the lot number on the packaging, which ranges from 6631603 to 7257040 with expiration dates from September 2023 to June 2024. The product is labeled as 'Integra Cranial Access Kit' for accessing the subarachnoid space or lateral ventricles of the brain.
Look for the lot number on the packaging, which is listed in the recall as ranging from 6631603 to 7257040 with specific expiration dates.
The sterile packaging for the Cranial Access Kit failed integrity testing, which could compromise product sterility during medical procedures.
Contact Integra LifeSciences directly for specific instructions on how to handle the recalled product. The recall does not specify a remedy.
The recalled kits have expiration dates from September 2023 through June 2024, with specific lot numbers listed in the recall.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1201-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1201-2024 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.
