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Teleflex Medical recalls RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Recalled July 24, 2019 · FDA recall Z-1974-2019 · Teleflex Medical
Hazard
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. · FDA Class III
Units
105426 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 is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Product
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →