Recall Z-1609-2014— RM Temena GmbH

Name: FDA recall Z-1609-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-19

Class II · Terminated

Class II FDA medical device recall by RM Temena GmbH, initiated 2014-03-19, terminated 2016-09-19. It names one FDA 510(k) clearance: K080603. 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. Reason: Ultrasound needles may be defective and leak at the needle hub..

Recalling firm: RM Temena GmbH
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Terminated: 2016-09-19
Firm location: Felsberg, Germany

510(k) clearances named in this recall

1 on FDA's record

K080603 — HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATEDTe ME NA Sas·cleared 2008-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.