ICU Medical recalls 25-pouch IV sets with potential manufacturing defect causing improper seal with spike. Affected lots may risk fluid leaks during use.
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-pouch IV sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to fluid leaks during medical use.
The IV set's internal surface may have a manufacturing defect that prevents it from sealing properly with the spike. This could allow fluid to leak during medical administration, potentially causing patient discomfort or complications.
Healthcare professionals using these IV sets for patient care. Patients receiving treatment with the affected sets are at risk of potential fluid leaks.
Check for the lot number 4630752 on the packaging. The product is a 126-inch (320cm) IV set with 25 pouches per case.
Look for lot number 4630752 on the packaging to confirm if your set is affected.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave that may prevent proper sealing with the spike.
Check the lot number on the packaging. If it's 4630752, contact ICU Medical for further instructions.
The recall states a potential manufacturing defect that may cause fluid leaks, but no specific injury risk is mentioned.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0245-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0245-2021 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.
