ICU Medical recalls 54-inch IV sets with a possible manufacturing defect causing seal failure. Affected units have specific UDI codes; stop using immediately if you own one.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
ICU Medical is recalling 54-inch IV sets that may have a manufacturing defect preventing proper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave stopcock in specific lots may not seal properly with the spike. This could allow fluid leakage or improper administration during medical procedures.
Healthcare professionals using these IV sets for patient care are most at risk. Patients receiving treatment with these sets could face complications if the seal fails.
Check for the UDI code: 0110840619082526(17)250201(30)50(10)4718579. The affected sets are 54 inches long and approximately 7.2 ml capacity.
If you have the affected IV set, stop using it right away to prevent potential fluid leakage or improper administration.
The UDI code is 0110840619082526(17)250201(30)50(10)4718579.
Check for the UDI code 0110840619082526(17)250201(30)50(10)4718579 on the set. Affected sets are 54 inches long and approximately 7.2 ml capacity.
The recall does not mention a fix; the remedy is null, so affected users should stop using the set immediately.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0216-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0216-2021 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.
