ICU Medical recalls 15-drop sets with specific lot numbers due to potential seal failure with NanoClave spikes. Affected units may not seal properly, risking contamination. 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 15-drop sets that may not seal properly with NanoClave spikes, potentially causing contamination. This affects specific lot numbers and could lead to infection risks during medical use.
The internal surface of the NanoClave in specific lots may not seal correctly with the spike, potentially allowing contaminants to enter the patient's bloodstream during use.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments with affected sets could face contamination.
Check for the lot number 4713954 on the packaging. The product includes 25 pouches per case with a unique identifier starting with (01)10887709089904.
Look for the lot number 4713954 on the packaging to confirm if your set is affected.
The affected lot number is 4713954.
Check for the lot number 4713954 on the packaging. The product includes 25 pouches per case with a unique identifier starting with (01)10887709089904.
The recall record 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-0228-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0228-2021 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.
