Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber… — Class II medical device recall Z-1358-2015
Terminated recall by C.R. Bard, Inc., reported 2015-04-08, distributed nationwide. Potential breach of the sterile barrier packaging.
| Recall number | Z-1358-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2015-01-30 |
| Classified | 2015-04-01 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 9,620 units |
| Reason classes | sterility |
| Lot numbers | NGYJ0603, NGYJ1671 |
Product
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Reason for recall
Potential breach of the sterile barrier packaging.
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-1358-2015. 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.