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Recall Observatory FDA recall evidence

Device product

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

Z-1010-2015

January 14, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 70102
Status
Terminated
Classification
Class II
Quantity
26,028 units
Official record key
device-enforcement:Z-1010-2015

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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