Z-1974-2019 Class III Terminated
FDA device recall Z-1974-2019 was initiated by Teleflex Medical on January 14, 2019 and is designated Class III. Reason for recall: 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 warn… The recall status is terminated (terminated December 13, 2022). Affected quantity: 105426 US eaches.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- January 14, 2019
- Termination Date
- December 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105426 US eaches
Product Description
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Code Information
GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701