Product Code 2C4013 — Class II medical device recall Z-1010-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-02-04. Potential for failure of the pouch packaging seal at high altitudes.
| Recall number | Z-1010-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-01-14 |
| Classified | 2015-01-26 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2017-04-10 |
| Quantity | 26,028 units |
| Reason classes | packaging |
| Lot numbers | UR13125045, UR13126035, UR13126043, UR131L06024, UR13K22031, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, UR14E20043 |
Product
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Reason for recall
Potential for failure of the pouch packaging seal at high altitudes.
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-1010-2015. 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.