Device product
98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Z-1594-2015
Product summary
- Event
- Event 71028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 900 units
- Official record key
device-enforcement:Z-1594-2015
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. 2997914 2997918 2998570 3001230 3001231
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.