Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Reported: February 4, 2015 Initiated: January 14, 2015 #Z-1010-2015
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 26,028 units
- Distribution
- US Distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m). Recalled by Baxter Healthcare Corp.. Units affected: 26,028 units.
Why was this product recalled? ▼
Potential for failure of the pouch packaging seal at high altitudes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1010-2015.
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