Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.…

Recall date
January 14, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1010-2015
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
US Distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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