FDA Device recall Z-1010-2015
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m) by Baxter Healthcare, citing potential for failure of the pouch packaging seal at high altitudes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-14 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Reason
Potential for failure of the pouch packaging seal at high altitudes.
Identifiers
| code_info | Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A170…Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2015%22
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