Integra LifeSciences recalls Bactisal Clear EVD Catheter sets with packaging defects that could 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 may compromise the product sterility.
Integra LifeSciences is recalling Bactisal Clear EVD catheter sets due to potential packaging defects that might compromise sterility. This could lead to infections during brain ventricle procedures if the catheter is used without proper sterility.
The external sterile packaging may have gaps or weaknesses in the seal, which could allow contamination. This might compromise the catheter's sterility during medical procedures, increasing infection risk.
Patients undergoing brain ventricle procedures requiring cerebrospinal fluid drainage may be affected. Medical professionals using the specific catheter sets with listed lot numbers are at risk.
Check for product number 821750 and lot numbers 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, or 7328569. The catheter is intended for brain ventricle access procedures to drain cerebrospinal fluid.
Verify the product number (821750) and lot numbers listed in the recall notice.
The external sterile packaging may have gaps or weaknesses that could compromise the product's sterility during medical procedures.
The packaging may have gaps or weaknesses in the seal that could allow contamination.
Check for product number 821750 and lot numbers 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, or 7328569.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2138-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2138-2024 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.
