medical Class III Updated 2019-07-24

Teleflex Medical recalls RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine c

Recalled Product

RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

Hazard / Issue

The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701
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