RUSCH — Class II medical device recall Z-0771-2017
Terminated recall by Teleflex Medical, reported 2016-12-28, distributed nationwide. Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the ac
| Recall number | Z-0771-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-16 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-11-24 |
| Distributed | Nationwide (US) |
| Quantity | 102,843 units |
| Reason classes | labeling |
| Lot numbers | 4A1600801, 74A1600023, 74A1600024, 74A1600799, 74A1600800, 74A1601105, 74A1601106, 74A1602234, 74A1602236, 74A1603122, 74A1603123, 74D1600231, 74D1600923, 74D1601540, 74D1601541, 74D1602007, 74D1602136, 74E1600845, 74E1600846, 74E1601768, 74E1602235, 74E1602237, 74E1602795, 74E1602796, 74E1602797, 74F1501853, 74F1501855, 74F1501857, 74F1501962, 74F1503201, 74F1601966, 74F1601988, 74G1600486, 74G1600723, 74G1600724, 74H1500530, 74H1500534, 74H1500978, 74H1500979, 74J1500576 and 12 more |
Product
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Reason for recall
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
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-0771-2017. 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.