ZOLL recalls COOL LINE Intravascular Heat Exchange Catheter kits with potential leaks from catheter or start-up kit tubing. Affected units have specific model and lot numbers. No action needed if not affected.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL is recalling a specific COOL LINE Intravascular Heat Exchange Catheter kit due to potential leaks from the catheter or start-up kit tubing. This could lead to complications if the tubing leaks during medical use.
The catheter or start-up kit tubing may leak during medical procedures, potentially causing complications such as infection or improper medication delivery. This is a labeling update issue rather than a defect in the product itself.
Healthcare professionals using the ZOLL COOL LINE catheter kit with central venous infusion capabilities. Patients receiving this treatment are at risk if leaks occur during medical procedures.
Check for the model number CL-2295CO on the kit packaging. The product is sold with the lot number (01)00849111075510 and is labeled as HEPARIN COATED, STERILE EO, Rx Only.
Verify the model number CL-2295CO and lot number (01)00849111075510 on the kit packaging.
The recall is for potential leaks from the catheter or start-up kit tubing, but no immediate action is needed if the product is not affected.
Check the model number and lot number on the packaging. If it matches, contact ZOLL for further instructions.
The recall does not include a remedy; the issue is addressed through labeling updates.
We’ve drafted a message you can send ZOLL to request your refund or repair — edit it as you like.
Subject: Recall Z-0044-2022 — ZOLL ZOLL Hello, I own a ZOLL that is covered by recall Z-0044-2022 from ZOLL. 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.
