—#156519

Product

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435
Affected lot / code info: Lot No. 3040897, 3085194, 3100137, 3125469, 3136083, 3284928, 3288396, 3309182. Item No. AM6100

Why it was recalled

The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: Productreturns@icumed.com.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.

Timeline

Recall initiated: 2017-05-30
Posted by FDA: 2017-06-26
Terminated: 2024-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.