Z-1975-2019 Class III Terminated
FDA device recall Z-1975-2019 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 would not affect the function/performance of the device itself. Other label information and warnings ar… The recall status is terminated (terminated December 13, 2022). Affected quantity: 76725 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
- 76725 US eaches
Product Description
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Code Information
GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701