Recall Z-2619-2014 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
| Date | Sep 19, 2014 (initiated Aug 19, 2014) |
| Status | Terminated |
| Reason | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. |
| Root cause | Nonconforming Material/Component |
| Action | 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: |
| Quantity | 3750 units |
| Distribution | Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |