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FDAJanuary 14, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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