Device product
119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Z-1588-2015
Product summary
- Event
- Event 71028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 units
- Official record key
device-enforcement:Z-1588-2015
Official wording
Reason: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
Code information: Lot No. 2977625 2992751 2995225
Distribution pattern: Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
Derived failure modes
-
Unknown
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.