Integra LifeSciences recalls Bactisal EVD catheter sets with packaging defects that may compromise sterility. Affected units include specific lot numbers and product codes for brain ventricle access procedures.
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Integra LifeSciences is recalling Bactisal EVD catheter sets that have a defect in the sterile packaging. This defect could allow contamination, making the catheter unsafe for brain surgery procedures.
The external sterile packaging has a gap or weakness in the seal. This could compromise the product's sterility, potentially leading to infections during brain surgery.
Patients undergoing brain surgery requiring ventricular drainage may be affected. Healthcare providers using the catheter sets for cerebrospinal fluid drainage are most at risk.
Check for product number 821745 and lot numbers 7320001, 7320004, 720005, 7322926, or 322927. The catheter set is used for brain ventricle access procedures.
Identify the product number (821745) and lot numbers (7320001, 7320004, 720005, 7322926, 322927) to confirm if your set is affected.
The external sterile packaging has a gap or weakness that may compromise sterility, risking infection during brain surgery.
Check the product number and lot numbers to see if your set is affected. If it is, contact Integra LifeSciences for further instructions.
The recall record does not mention a remedy or fix for the packaging defect.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2136-2024 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.
