ICU Medical recalls specific lots of 15-drop admin sets due to potential seal failure with NanoClave spikes. Affected units may not seal properly, risking improper fluid administration. Contact for replacement.
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 certain lots of 15-drop admin sets because a manufacturing defect might prevent the NanoClave spike from sealing properly. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave manifold in specific lots may have a defect that prevents it from creating a proper seal with the NanoClave spike. This could result in improper fluid administration during medical procedures.
Healthcare professionals using these specific lots of 15-drop admin sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could experience improper fluid delivery.
Check the lot numbers: 4556713, 4603383, or 4573356. The product is a 139" (353 cm) 15-drop admin set with a NanoClave manifold and check valve.
Identify the lot number on the product label to determine if it is affected (4556713, 4603383, or 4573356).
Reach out to ICU Medical for replacement or further instructions if the product is affected.
The internal surface of the NanoClave manifold in specific lots may have a defect that prevents proper sealing with the NanoClave spike.
Check the lot numbers: 4556713, 4603383, or 4573356. The product is a 139" (353 cm) 15-drop admin set with a NanoClave manifold and check valve.
Contact ICU Medical for replacement or further instructions if the product 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-0233-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0233-2021 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.
