RUSCH CARE Premium Drain bag — Class III medical device recall Z-1974-2019
Terminated recall by Teleflex Medical, reported 2019-07-24, distributed nationwide. The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely
| Recall number | Z-1974-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2019-01-14 |
| Classified | 2019-07-15 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2022-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, CA, GT, JM, PE, SV, TT |
| Quantity | 105,426 us |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 14026704645708 |
| Lot numbers | 20161005, 20161120, 20161125, 20170105, 20170210, 20170301, 20170401, 20170402, 20170501, 20170601, 20170701, 20170801, 20170802, 20170902, 20170904, 20171001, 20171101, 20171201, 20180101 |
| Model numbers | 390000 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1974-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.