FDA Device recall Z-1975-2019
RUSCH Urinary Drainage bag, 2000mlm REF 390060 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 Urinary Drainage bag, 2000mlm REF 390060 urine collection device by Teleflex Medical, citing 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 inform….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1975-2019 |
| 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 Urinary Drainage bag, 2000mlm REF 390060 urine collection device
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.
Identifiers
| code_info | GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170…GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 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-1975-2019%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.