Baxter Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-1010-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

Product Classification:

Class II

Date Initiated: January 14, 2015

Date Posted: February 4, 2015

Recall Number: Z-1010-2015

Event ID: 70102

Reason for Recall:

Potential for failure of the pouch packaging seal at high altitudes.

Status: Terminated

Product Quantity: 26,028 units

Code Information:

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

Distribution Pattern:

US Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated