ICU Medical recalls 50 pouches of Smallbore Ext Set w/NanoClave due to potential seal failure with the spike. Affected units have specific lot numbers. Consumers should check their product for the listed serial numbers.
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 pouches of Smallbore Ext Set w/NanoClave sets because a manufacturing defect might prevent the NanoClave from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that prevents it from creating a proper seal with the spike. This could lead to improper fluid administration during medical procedures.
Patients receiving medical treatments using this specific set may be affected. Healthcare professionals using the recalled units are at risk of potential improper fluid administration.
Check for the lot numbers: 4603285, 4630700, 4749870, 4514843, 4549093, 4558478, 4724850, or 4734400. The product is a single-use sterile medical device sold in 50 pouches per case.
Look for the lot numbers listed: 4603285, 4630700, 4749870, 4514843, 4549093, 4558478, 4724850, or 4734400.
ICU Medical is recalling 50 pouches of Smallbore Ext Set w/NanoClave, a single-use sterile medical device for fluid administration.
Check the lot numbers on your product: 4603285, 4630700, 4749870, 4514843, 4549093, 4558478, 4724850, or 4734400.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0278-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0278-2021 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.
