Catheter Research, Inc recalls HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalping

Recalled April 29, 2015 · FDA recall Z-1481-2015 · Catheter Research

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. · FDA Class II

Units

880 units

Sold at

Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None

Description

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

Product

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

Manufacturer(s)

Catheter Research, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →