—#129607

Product

STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. 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 # 2768417

Why it was recalled

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to this recall were 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. For questions regarding this recall call 801-264-1732.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.

Timeline

Recall initiated: 2014-08-19
Posted by FDA: 2014-09-19
Terminated: 2014-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.