Device product
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
Z-1608-2014
Product summary
- Firm
- RM Temena GmbH
- Event
- Event 68026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7370 needles
- Official record key
device-enforcement:Z-1608-2014
Official wording
Reason: Ultrasound needles may be defective and leak at the needle hub.
Code information: Lot B3170005, EXP 2018-05-31
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.