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FDAApril 7, 2015device

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

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

The hazard

HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

What to do

FDA enforcement status: Terminated

Brands named

catheter researchcatheter

Recall history

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

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