ICU Medical recalls 50-pouch sets with specific lot numbers due to a potential manufacturing defect that may prevent proper sealing with the NanoClave spike.
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 50-pouch sets of small-bore IV administration sets because a manufacturing defect might cause improper sealing with the NanoClave spike. This could lead to leaks or infections during medical use.
The defect may prevent the NanoClave spike from sealing properly with the set, potentially causing leaks or infections during medical procedures. This is a manufacturing issue that affects specific lot numbers.
Healthcare professionals using these IV sets for patient care are most at risk. Patients receiving treatment with these sets could face potential leaks or infections.
Check for the lot numbers 4572801, 4589920, or 4572950 on the packaging. These sets are sold in 50-pouch cases with a specific UDI code format.
Look for lot numbers 4572801, 4589920, or 4572950 on the packaging to identify affected units.
The recall states a potential manufacturing defect on the internal surface of the NanoClave that may inhibit proper sealing with the NanoClave spike.
Check for lot numbers 4572801, 4589920, or 4572950 on the packaging. These sets are sold in 50-pouch cases with a specific UDI code format.
The recall does not specify a stop-use instruction, so you do not need to stop using them immediately. However, check the lot numbers to confirm if your set is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0207-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0207-2021 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.
