ICU Medical recalls 50 units of Smallbore Ext Set with NanoClave sets that may have a manufacturing defect causing improper seal with the spike. Affected units have specific lot numbers and UDI codes.
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 units of Smallbore Ext Set with NanoClave sets due to a potential manufacturing defect that could prevent proper sealing with the spike. This defect might lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave to not seal properly with the spike, potentially allowing fluid leakage or improper administration. This could lead to incorrect dosing or contamination during medical procedures.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the specific lot numbers: 4572814, 4724859, or 4734417. The product has a unique identifier (UDI) code starting with (01)10887709049496, (01)10887709087526, or (01)10887709087526.
Look for the lot numbers 4572814, 4724859, or 4734417 on the packaging.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the spike.
Check the lot numbers: 4572814, 4724859, or 4734417. The product also has a unique identifier (UDI) code starting with (01)10887709049496, (01)10887709087526, or (01)10887709087526.
The recall does not specify a stop-use instruction, so you can continue using them if you have verified the 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-0208-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0208-2021 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.
