Integra LifeSciences recalls CODMAN EVD BACTISEAL 1.9mm catheter sets due to potential packaging defects that could compromise sterility. Affected units include specific lot numbers and product codes.
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 CODMAN EVD BACTISEAL 1:9mm catheter sets because the sterile packaging might have gaps or weaknesses that could allow contamination. This is serious because brain surgery uses these catheters to drain fluid, and contamination could lead to infections.
The catheter's sterile packaging has a potential gap or weakness in the seal. If the seal fails, contaminants could enter the catheter, risking infection during brain surgery or procedures that drain cerebrospinal fluid.
Patients undergoing brain surgery or procedures requiring cerebrospinal fluid drainage are most at risk. Healthcare providers using the catheter set for medical procedures may also be affected.
Check for product number 821749 and lot numbers 7314912, 7320010, or 7322933. The catheter set is used for brain ventricles and draining cerebrospinal fluid.
Verify the product number (821749) and lot numbers (7314912, 7320010, 7322933) to confirm if your set is affected.
The sterile packaging may have gaps or weaknesses that could compromise the product's 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 is due to potential contamination risks during medical procedures, not direct injury from the defect itself.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2137-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2137-2024 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.
