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Z-1010-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1010-2015 was initiated by Baxter Healthcare Corp. on Jan 14, 2015 and is designated Class II. Reason for recall: Potential for failure of the pouch packaging seal at high altitudes. The recall status is terminated (terminated Apr 10, 2017). Affected quantity: 26,028 units.

Recall Details

Product Type: Devices
Report Date: Feb 4, 2015
Initiation Date: Jan 14, 2015
Termination Date: Apr 10, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26,028 units

Product Description

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.

Distribution Pattern

US Distribution.

Code Information

Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1010-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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