HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingo
FDA device recall Z-1481-2015 · posted 2015-04-21 · Terminated
Recall details
- Recalling firm
- Catheter Research, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HGS
- Quantity affected
- 880 units
- Distribution
- Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
- Date initiated
- 2015-04-07
- Date posted
- 2015-04-21
- Date terminated
- 2015-07-17
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| H/S CATHETER SET (K032835) | Catheter Research, Inc. | 2003-12-11 |