Integra recalls Cranial Access Kit (Ref No: HITHSP04) due to potential sterility compromise from defective packaging. Affected units include 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 is recalling a Cranial Access Kit used for brain surgery access because its sterile packaging might not be intact, risking infection. This is serious for medical procedures but only affects specific batches.
The sterile packaging for the Cranial Access Kit failed integrity testing, meaning the kit might not be sterile. If the packaging is compromised, it could lead to infections during surgery.
Healthcare professionals using the kit for brain surgery procedures are most at risk. Patients undergoing these procedures could be affected if the kit is used without proper sterility.
Check for the lot number 7257028 and expiration date 1-Jun-24 on the packaging. The product is identified by Ref No: HITHSP04.
Inspect the header bag for signs of damage or leaks that might indicate compromised sterility.
Reach out to Integra LifeSciences Corp. for specific guidance on affected units and next steps.
The recall affects healthcare professionals using the kit. Patients are not directly affected unless the kit is used without proper sterility.
Look for lot number 7257028 and expiration date 1-Jun-24 on the packaging. The product is identified by Ref No: HITHSP04.
Check the packaging for integrity and contact Integra LifeSciences Corp. for specific guidance on affected units.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1194-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1194-2024 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.
