Integra LifeSciences recalls cranial access kits without prep solutions due to potential packaging tears that could compromise sterility during ventriculostomy procedures.
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Integra LifeSciences is recalling cranial access kits used in ventriculostomy procedures because the sterile packaging might tear, risking infection. This affects specific lot numbers and catalog numbers.
The sterile packaging of the cranial access kit may develop holes or tears, which could allow contamination and lead to infection during surgery. This risk occurs because the packaging is designed to be sterile but may not hold that condition without damage.
Medical professionals using the cranial access kits during ventriculostomy procedures. Patients undergoing the procedure are at risk if the kit's packaging is compromised.
Check for the catalog number INS5HND or lot numbers listed: 7257032 (07/16/2025), 7275713 (09/03/2025), 7291974 (09/03/2025), 7312131 (09/03/2025), 7289690 (09/03/2025), 7291975 (09/03/2025), 7312137 (09/03/2025), 7312139 (09/03/2025).
Inspect the sterile header bag for any holes or tears before use.
Integra Cranial Access Kit (without Prep solutions) used during ventriculostomy procedures, with catalog number INS5HND.
Lot numbers 7257032 (07/16/2025), 7275713 (09/03/2025), 7291974 (09/03/2025), 7312131 (09/03/2025), 7289690 (09/03/2025), 7291975 (09/03/2025), 7312137 (09/03/2025), and 7312139 (09/03/2025).
The recall record does not specify a remedy.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1873-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1873-2024 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.
