Recall Z-1481-2015 ยท HGS Catheter, Intrauterine And Introducer
Catheter Research, Inc
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
| Date | Apr 21, 2015 (initiated Apr 7, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 880 units |
| Distribution | Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032835 | H/S CATHETER SET Catheter Research, Inc., Dec 11, 2003 |