ICU Medical recalls 100 NanoClave Connector pouches with specific lot numbers due to a potential manufacturing defect that may prevent proper sealing with the spike. Affected units could lead to improper connections during medical procedures.
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 specific lots of NanoClave Connectors because a manufacturing defect might prevent the connector from sealing properly with the spike. This could lead to improper connections during medical procedures, especially for patients needing blood or fluid administration.
The connector's internal surface may have a manufacturing defect that prevents it from sealing correctly with the spike. This could lead to improper connections during medical procedures, potentially causing issues with fluid administration or blood delivery to patients.
Patients using the NanoClave Connector for blood or fluid administration, particularly those in pediatric or immunocompromised care. Healthcare providers using the device in medical settings are most at risk.
Check the lot numbers on the NanoClave Connector pouches: 4573278, 4590919, 4712217, 4537440, 4549906, 4559515, 4719743, 4726897, 4735597, or 4461205. The product is sold in pouches with 1 unit per pouch and 100 pouches per case.
Identify the lot number on the NanoClave Connector pouch to see if it matches the affected lots listed: 4573278, 4590919, 4712217, 4537440, 4549906, 4559515, 4719743, 4726897, 4735597, or 4461205.
The NanoClave Connector is a bidirectional connector intended for use with intravascular catheters to administer blood and fluids to patients, including those in pediatrics and immunocompromised care.
100 pouches per case, with 1 unit per pouch, and specific lot numbers listed in the recall.
The recall record does not specify a remedy; affected units should be checked against the listed lot numbers.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0261-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0261-2021 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.
