Recall Z-1590-2015 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
| Date | May 7, 2015 (initiated Apr 20, 2015) |
| Status | Terminated |
| Reason | ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. |
| Root cause | Under Investigation by firm |
| Action | 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 ques |
| Quantity | 1,500 units |
| Distribution | Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |