Device product
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Z-1609-2014
Product summary
- Firm
- RM Temena GmbH
- Event
- Event 68026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7370 needles
- Official record key
device-enforcement:Z-1609-2014
Official wording
Reason: Ultrasound needles may be defective and leak at the needle hub.
Code information: Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30
Distribution pattern: US Distribution including the states of MD and IL.
Derived failure modes
-
Unknown
Ultrasound needles may be defective and leak at the needle hub.