RM Temena GmbH

Medical device manufacturer in Felsberg, Germ.

0510(k) clearances
0PMA approvals
2recalls

Recalls

RecallProductInitiated
Z-1609-2014 Class IIUltrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box…Ultrasound needles may be defective and leak at the needle hub. 03/19/2014Terminated
Z-1608-2014 Class IIUltrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item…Ultrasound needles may be defective and leak at the needle hub. 03/19/2014Terminated