Z-1609-2014 Class II Terminated
FDA device recall Z-1609-2014 was initiated by RM Temena GmbH on March 19, 2014 and is designated Class II. Reason for recall: Ultrasound needles may be defective and leak at the needle hub. The recall status is terminated (terminated September 19, 2016). Affected quantity: 7370 needles.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- March 19, 2014
- Termination Date
- September 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7370 needles
Product Description
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
Reason for Recall
Ultrasound needles may be defective and leak at the needle hub.
Distribution Pattern
US Distribution including the states of MD and IL.
Code Information
Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30