Integra LifeSciences recalls Cranial Access Kits with potential sterility issues due to defective packaging. Affected units 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 packaging defects compromising sterility. This could lead to infections if used in medical procedures. The recall affects specific lot numbers and expiration dates.
The sterile packaging for the Cranial Access Kit failed integrity testing, potentially allowing contamination. If the kit is used without proper sterility, it could cause infections during medical procedures.
Medical professionals using the Cranial Access Kit for brain procedures are most at risk. The recall applies to specific lot numbers produced between September 2023 and April 2024.
Check the product label for lot numbers listed in the recall (e.g., 6631607, 6631608). The kits were sold between September 2023 and April 2024 with specific expiration dates.
Look for lot numbers on the kit's label that match the listed numbers in the recall (e.g., 6631607, 6631608).
The sterile packaging (header bag) failed integrity testing, potentially compromising sterility.
Check the product label for lot numbers listed in the recall, such as 6631607 or 6631608, which were produced between September 2023 and April 2024.
The recall does not require immediate discontinuation; affected units should be checked for lot numbers and contacted for further instructions.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1203-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1203-2024 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.
