FDA-Device2015-02-04Class II

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

Baxter Healthcare Corp.
Hazard

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

Sold states
US Distribution.
Affected count
26,028 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2015

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