Medical DeviceMay 21, 2014
RM Temena GmbH Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 recall — FDA Z-1609-2014
Ultrasound needles may be defective and leak at the needle hub.
Class IIFDA: TerminatedRM Temena GmbH
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMay 21, 2014
RM Temena GmbH Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 recall — FDA Z-1608-2014
Ultrasound needles may be defective and leak at the needle hub.
Class IIFDA: TerminatedRM Temena GmbH
Understanding this recall history
This page summarizes recall records in which the official source identifies RM Temena GmbH as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.