Recall Z-1481-2015— Catheter Research, Inc

Name: FDA recall Z-1481-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-07

Class II · Terminated

Class II FDA medical device recall by Catheter Research, Inc, initiated 2015-04-07, terminated 2015-07-17. It names one FDA 510(k) clearance: K032835. Product: HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.. Reason: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa..

Recalling firm: Catheter Research, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-07
Terminated: 2015-07-17
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032835 — H/S CATHETER SETCatheter Research, Inc.·cleared 2003-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.