ICU Medical recalls 50-pouch sets with incorrect spin collar that could cause improper function during medical use. Affected units include specific lot numbers and model A1254.
The infusion sets were manufactured with an incorrect spin collar.
ICU Medical is recalling 50-pouch sets with an incorrect spin collar that could lead to improper function during medical use. This recall affects patients receiving intravenous treatments.
The infusion sets were manufactured with an incorrect spin collar, which could cause improper function during medical use. This might lead to incorrect fluid administration or other complications.
Patients using intravenous treatments with the recalled sets are affected. Healthcare providers who use these sets for medical procedures are most at risk.
Check for the model number A1254 on the label. The sets were sold with lot numbers 3533699 and 3549590, and were distributed by ICU Medical in San Clemente, CA.
Look for the model number A1254 and lot numbers 3533699 or 3549590 on the label.
The model number is A1254.
Lot numbers 3533699 and 3549590 are affected.
Check for the model number A1254 and lot numbers 3533699 or 3549590 on the label.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1343-2018 from ICU Medical. 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.
