Recall Z-0662-2008 ยท MQF Catheter, Assisted Reproduction
Fertility Technology Resources, Inc.
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
| Date | Jan 19, 2008 (initiated Sep 13, 2007) |
| Status | Terminated |
| Reason | Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance. |
| Root cause | Process design |
| Action | 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. |
| Quantity | not reported |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023017 | TUCKER EMBRYO CATHETER Fertility Technology Resources, Inc., Dec 13, 2002 |