FDA-Device2014-05-21Class II
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
RM Temena GmbH
Hazard
Ultrasound needles may be defective and leak at the needle hub.
Sold states
US Distribution including the states of MD and IL.
Affected count
7370 needles
Manufactured in
Mittelhoefer Str. 1, D-34587, Felsberg, Germany
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2014Don't want to check this manually?
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