FDAFDA · Food and drugs·Recall number Z-1010-2015
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Published February 4, 2015 · Recall initiated: January 14, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for failure of the pouch packaging seal at high altitudes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- US Distribution.
- Lot
- Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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