Integra LifeSciences recalls CODMAN HAK: BACTISEAL shunt systems with incorrect labeling that may affect peritoneal catheter function. Learn if your device is affected and what to do.
Incorrect labeling, Catheter did not have the required holes and markings
Integra LifeSciences is recalling a specific peritoneal catheter used in hydrocephalus treatment due to incorrect labeling. This could mean the catheter lacks required drainage holes and markings, potentially causing improper function.
The catheter may not have the required drainage holes and markings, which are critical for proper function in hydrocephalus treatment. Incorrect labeling could lead to improper drainage or system failure.
Patients with hydrocephalus who use the CODMAN HAKIM BACTISEAL Shunt System. Those with the specific model and lot numbers are most at risk.
Check for the model name 'CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm' and lot number 5028205. The product was sold with catalog number NS5524.
Verify the lot number and catalog number to confirm if your device is affected.
The recall indicates potential incorrect labeling that could affect function, but the device may still be safe if properly labeled. Consult your healthcare provider.
Check the lot number and catalog number to see if it's affected. If it is, contact Integra LifeSciences for guidance.
Look for the model name 'CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm' and lot number 5028205.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1354-2021 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1354-2021 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.
