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Teleflex Medical recalls RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Recalled July 24, 2019 · FDA recall Z-1975-2019 · Teleflex Medical
Hazard
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling. · FDA Class III
Units
76725 US eaches
Sold at
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Description
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Product
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →