FDA-Device2015-04-29Class II
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Catheter Research, Inc
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.
Sold states
Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
Affected count
880 units
Manufactured in
5610 W 82nd St, Indianapolis, IN, United States
Products
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2015Don't want to check this manually?
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