ICU Medical recalls 15-drop IV sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the NanoClave spike, requiring immediate action.
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 15-drop IV sets that could have a manufacturing defect causing improper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may not seal properly with the NanoClave spike. This defect 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 affected sets could experience improper fluid administration.
Check for lot numbers 4711125 or 4718711 on the packaging. The product is a 128-inch (325 cm) 15-drop primary set with specific components.
Look for lot numbers 4711125 or 4718711 on the packaging to identify affected units.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave in specific lots, which may inhibit a proper seal with the NanoClave spike.
Check the lot number on the packaging. If it is 4711125 or 4718711, stop using the product and contact ICU Medical for further instructions.
The recall states a potential seal failure, which could lead to improper fluid administration during medical procedures, but the remedy is not specified in the record.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0244-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0244-2021 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.
