ICU Medical recalls 25 pouches of 15-drop sets due to possible seal failure in specific lots. Affected units may not seal properly with the spike, risking improper fluid administration.
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 25 pouches of 15-drop sets that may have a manufacturing defect causing the seal to fail with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave sets may have a defect that prevents a proper seal with the spike. This could lead to improper fluid administration if the seal fails during use.
Patients using these specific 15-drop sets for medical fluid administration are affected. Healthcare providers and medical facilities that use the recalled sets are most at risk.
Check for the lot numbers: 4573948, 4603380, 4711169, 4493653, 4536737, or 4733710. The product is a single-use sterile device sold in 25 pouches per case.
Look for the lot numbers listed: 4573948, 4603380, 4711169, 4493653, 4536737, or 4733710.
ICU Medical is recalling 25 pouches of 15-drop sets (NanoClave) with specific lot numbers: 4573948, 4603380, 4711169, 4493653, 4536737, and 4733710.
The internal surface of the NanoClave sets may have a manufacturing defect that prevents a proper seal with the spike, potentially leading to improper fluid administration.
Check the lot numbers on the product: 4573948, 4603380, 4711169, 4493653, 4536737, or 4733710. The product is a single-use sterile device sold in 25 pouches per case.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0227-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0227-2021 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.
