Device product
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Z-1975-2019
Product summary
- Firm
- Teleflex Medical
- Event
- Event 81954
- Status
- Terminated
- Classification
- Class III
- Quantity
- 76725 US eaches
- Official record key
device-enforcement:Z-1975-2019
Official wording
Reason: 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.
Code information: GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Derived failure modes
-
Unknown
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.