ICU Medical recalls 50-pouch sets of small bore IV connectors due to potential seal failure with NanoClave spikes. Affected units have specific lot 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 small bore IV sets that may have a manufacturing defect causing improper sealing with NanoClave spikes. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave connector may have a manufacturing defect that prevents it from sealing properly with the NanoClave spike. This could allow fluid to leak or not flow correctly during medical procedures.
Healthcare professionals using these IV sets for patient care. Patients receiving IV treatments with affected sets are at risk of improper fluid administration.
Check for lot numbers: 4603240, 4714349, 4733540, 4724812, 4515226, 4537113, 4557474, 4718500, 4557476, or 4590957. The product is a single-use IV set with a NanoClave T-connector.
Look for the lot numbers listed: 4603240, 4714349, 4733540, 4724812, 4515226, 4537113, 4557474, 4718500, 4557476, or 4590957.
The internal surface of the NanoClave connector may have a manufacturing defect that could prevent proper sealing with the NanoClave spike.
Check the lot numbers: 4603240, 4714349, 4733540, 4724812, 4515226, 4537113, 4557474, 4718500, 4557476, or 4590957.
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-0183-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0183-2021 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.
