RM Temena GmbH: Medical Device Recall in 2014 - (Recall #: Z-1609-2014)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
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
Product Classification:
Class II
Date Initiated: March 19, 2014
Date Posted: May 21, 2014
Recall Number: Z-1609-2014
Event ID: 68026
Reason for Recall:
Ultrasound needles may be defective and leak at the needle hub.
Status: Terminated
Product Quantity: 7370 needles
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.
Voluntary or Mandated:
Voluntary: Firm initiated