ZOLL recalls ICY Intravascular Heat Exchange Catheter Kit with central venous infusion. Potential leaks from catheter or start-up kit tubing may cause complications. Affected units have specific model and lot numbers.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities due to potential leaks from the catheter or start-up kit tubing. This could lead to complications if the leaks cause fluid or medication to enter unintended areas.
The catheter or start-up kit tubing may leak, potentially causing fluid or medication to enter unintended areas. This could lead to complications such as infection or improper medication delivery if not addressed.
Healthcare professionals using the ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities are likely affected. Those who have the specific model and lot numbers listed in the recall are most at risk.
Check for the model number IC-3893AE and lot number (01)00849111075220 on the product. The kit is labeled as sterile, requires a prescription, and has specific use for central venous infusion.
Verify the model number IC-3893AE and lot number (01)00849111075220 on the product label.
The recall is due to potential leaks from the catheter or start-up kit tubing, which could cause complications. The product is not safe to use without addressing the leak risk.
Check the product label for the model number IC-3893AE and lot number (01)00849111075220. If you have the affected product, contact ZOLL for further instructions.
The affected product has the model number IC-3893AE and lot number (01)00849111075220. Check the label on the product for these details.
We’ve drafted a message you can send ZOLL to request your refund or repair — edit it as you like.
Subject: Recall Z-0046-2022 — ZOLL ZOLL Hello, I own a ZOLL that is covered by recall Z-0046-2022 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.
