—#135872

Product

113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

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. 2992754 3004256 3007508

Why it was recalled

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com.

Recalling firm

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

Distribution

Distribution pattern: Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

Timeline

Recall initiated: 2015-04-20
Posted by FDA: 2015-05-07
Terminated: 2015-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.