Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1481-2015 · Posted 2015-04-21

Recalling FirmCatheter Research, Inc
Recall StatusTerminated
Product CodeHGS
Date Initiated2015-04-07
Date Terminated2015-07-17
Product Quantity880 units

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.

Firm Action

Catheter Research, Inc. (CRI) has initiated a voluntary medical device removal of HSG Tray/ 5F HS Catheter Combo, and issued letters to customer son 04/07/2015 by e-mail and certified mail. Customers are asked to inspect their inventory and return recalled devices to CRI for replacement. If the devices were further distributed CRI requested customers provide notice of the recall. Customers may contact Babacar Diouf, VP of RA and QS, at (317) 872-0074 ext. 3512.

Root Cause

Packaging process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032835H/S CATHETER SETCatheter Research, Inc. · 2003-12-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑