Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
This recall has been terminated (originally issued January 19, 2008).
- Recall Initiated
- September 13, 2007
- Posted
- January 19, 2008
- Terminated
- February 6, 2008
- Recall Number
- Z-0662-2008
- Quantity
- not reported
- Firm Location
- Marietta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.
Distribution
Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.
Lot / Code Info
All units shipped before August 17, 2007
Root Cause
Process design
Action Taken
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.