ICU Medical recalls 50 pouches of NanoClave T-connector sets due to potential seal failure with spikes. Affected units have specific UDI codes and lot numbers. Consumers should contact for details.
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 50 pouches of NanoClave T-connector sets because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper use or failure of the medical device.
The internal surface of the NanoClave connector in certain lots may not seal properly with the spike. This could cause leaks or improper function during medical procedures, but the risk is not severe under normal use.
Healthcare professionals using the NanoClave T-connector sets for medical procedures are most at risk. The recall affects specific units with the UDI code (01)1088770: 4599980.
Check for the UDI code (01)10887709052809(17)250101(30)50(10)4599980 on the packaging. The affected units are in specific lots with the lot number 4599980.
Look for the UDI code (01)10887709052809(17)250101(30)50(10)4599980 on the packaging to confirm if your unit is affected.
The internal surface of the NanoClave connector in specific lots may not seal properly with the spike, potentially causing leaks or improper function.
50 pouches (1 unit per pouch) with the lot number 4599980.
The recall does not require immediate stop-use; affected units should be checked for the UDI code and lot number.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0185-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0185-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
