Reported Apr 29, 2015 · Terminated

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and…

Catheter Research, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Catheter Research, Inc · 5610 W 82nd St · Indianapolis, IN · 46278-1300

Is this the product you have?

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

Lot codes and dates: Model Number/Catalogue/Product Number
TMI1160
61-5205
TMI1198
KM61-5205
61-3205
Lot codes
J436A
J436B
J436C
J436D
J437A
J437B
J437C
J437D
Exp. J436 (2017-03)
J437 (2017-03)
Amount recalled: 880 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where it was distributed

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