Baxter Recalls Four Lead TUR Irrigation Sets Due to Seal Failure Risk
Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging seal failure at high altitudes, which is a potential defect without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Baxter Healthcare Corp. is recalling 26,028 units of Product Code 2C4013, Four Lead TUR Irrigation Sets. These sets are used with UROMATIC Plastic Containers and have an approximate length of 85 inches (2.2 meters). The affected units were distributed in the United States.
The recall was initiated due to a potential failure of the pouch packaging seal at high altitudes. This defect could compromise the integrity of the packaging. The recall covers specific lot numbers, including UR13125045, UR13126035, and UR13126043, among others.
Healthcare facilities and consumers should check their inventory for the affected lot numbers. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 26,028
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Lot numbers: UR13125045
- UR13126035
- UR13126043
- UR13K22031
- UR131L06024
- UR13L09077
- UR13L10042
- UR13L17047
- UR14A17048
- UR14A21057
- UR14B05017
- UR14B26039
- UR14C06039
- UR14C13068
- UR14C27035
- UR14D15046
- and UR14E20043
Distribution
Distribution scope not specified by the agency.
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