Cook recalls VentriClear Ventricular Drainage Catheter Set (lot : 8639185) due to endotoxin testing failure. This may cause immune reactions from mild fever to life-threatening systemic inflammation.
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Cook is recalling a specific lot of VentriClear Ventricular Drainage Catheter Sets because they failed endotoxin testing. This could cause immune reactions ranging from mild fevers to life-threatening systemic inflammation.
The catheter failed endotoxin testing, meaning it may contain harmful bacterial components. These can trigger immune responses, starting with mild fevers and potentially progressing to severe systemic inflammation that could be life-threatening.
Patients using this catheter for brain fluid drainage are at risk. Healthcare providers who have this specific lot number should stop using it immediately.
Check for the lot number 8639185 on the catheter packaging. This product was sold for short-term brain fluid drainage procedures.
Immediately stop using the VentriClear Ventricular Drainage Catheter Set with lot number 8639185.
This lot failed endotoxin testing, which may cause immune reactions ranging from mild fevers to life-threatening systemic inflammation.
Immediately stop using it and contact your healthcare provider for guidance.
The recall record does not mention a replacement or remedy.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-2791-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-2791-2018 from Cook. 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.
