Integra recalls cranial access kits with potential sterility compromise due to packaging defects. Affected units include 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 is recalling cranial access kits that may have packaging defects risking sterility. This could lead to infections if the kit is used in medical procedures without proper sterility.
The sterile packaging may fail integrity testing, potentially allowing contamination. If the kit is not sterile, it could cause infections during medical procedures.
Medical professionals using the cranial access kits for brain procedures are most at risk. Patients undergoing surgery with these kits could face infection if sterility is compromised.
Check for lot number 7257029 and expiration date 1-Jun-24 on the packaging. The product is labeled as Ref No: HITHSP06 / Integra Cranial Access Kit.
Reach out to Integra LifeSciences Corp. for specific instructions on affected units and next steps.
The recall indicates potential sterility compromise from packaging defects, which could lead to infections if the kit is used improperly. However, the risk level is low.
Look for lot number 7257029 and expiration date 1-Jun-24 on the packaging. The product is labeled as Ref No: HITHSP06 / Integra Cranial Access Kit.
Contact Integra LifeSciences Corp. for specific instructions on affected units and next steps.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1195-2024 — Integra Integra Hello, I own a Integra that is covered by recall Z-1195-2024 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.
