FDA Device recall Z-1974-2019
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
- FDA Device
- Class III
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class III recall of RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device by Teleflex Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1974-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-14 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Reason
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.
Identifiers
| code_info | GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 2017…GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1974-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.