Integra LifeSciences recalls a cranial access kit combo (INS-8301, INS-4500, INS-HITH) due to potential sterility compromise from defective packaging. Affected units have UDI 10381780178255 and lot 7281021 expiring April 1, 2024.
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 a cranial access kit combo that may have packaging defects compromising sterility. This could lead to infections if used in medical procedures.
The sterile packaging for the cranial access kit failed integrity testing, potentially allowing contamination. This could cause infections during medical procedures if the kit is used without proper sterility.
Medical professionals using the kit for brain surgery or spinal procedures are most at risk. Patients receiving the kit during surgery may be affected if the packaging defect leads to contamination.
Check for the unique device identifier (UDI) 10381780178255 and lot number 7281021 on the packaging. The kit expires April 1, 2024, and contains INS-8301, INS-4500, and INS-HITH components.
Look for UDI 10381780178255 and lot number 7281021 on the packaging to confirm if the kit is affected.
Yes, this cranial access kit is designed for procedures involving the subarachnoid space or lateral ventricles of the brain.
The affected kit expires April 1, 2024, with lot number 7281021.
Check for the unique device identifier (UDI) 10381780178255 and lot number 7281021 on the packaging.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1193-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1193-2024 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.
