107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Recall
- Recall Number
- Z-1589-2015
- Event Number
- 71028
- Firm
- ICU Medical, Inc.
- FEI Number
- 2025816
- Product Code
- FMG
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 20, 2015
- Posted
- May 7, 2015
- Terminated
- November 24, 2015
- Address
- 951 Calle, Amanecer San Clemente, CA, 92673-6212
Description
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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 [email protected]. 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: [email protected].
Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
600 units