HSG Trays/HS 5F Catheter Combo recalled over labeling errors

Recall date

April 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1481-2015

FDA classification

Class II

Brand / firm

Catheter Research, Inc

Sold / distributed

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

Why it was recalled

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

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

What was recalled

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