ICU Medical recalls 14 cm (5.5") Appx 0.27 ml Smallbore Ext Sets with incorrect spin collar. These sets may cause disconnection during use. Affected units have specific lot numbers.
The infusion sets were manufactured with an incorrect spin collar.
ICU Medical is recalling certain infusion sets that were manufactured with an incorrect spin collar. This could lead to disconnection during use, potentially causing complications for patients receiving medical treatment.
The infusion sets have an incorrect spin collar that may cause the set to disconnect during use. This could lead to interruptions in patient treatment or potential complications if fluids are not properly administered.
Healthcare professionals using these infusion sets for patient care. Patients receiving treatment with the recalled sets are at risk if the sets disconnect during use.
Check for the product name: 14 cm (5.5") Appx 0.27 ml Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case. Look for lot numbers 3422861, 3489493, 3498769, or 3498773 on the packaging.
Identify the product by checking the lot numbers listed: 3422861, 3489493, 3498769, or 3498773.
The infusion sets were manufactured with an incorrect spin collar that may cause disconnection during use.
Check for the product name: 14 cm (5.5") Appx 0.27 ml Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case. Look for lot numbers 3422861, 3489493, 3498769, or 3498773 on the packaging.
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-1347-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1347-2018 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.
