Recall Z-0664-2008
Fertility Technology Resources, Inc. · initiated September 13, 2007
Product
Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
Codes / lots: All units shipped before August 17, 2007
Reason for recall
Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
FDA-determined 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.
Details
- Recall number
- Z-0664-2008
- Initiated
- September 13, 2007
- Posted by FDA
- January 19, 2008
- Terminated
- February 6, 2008
- Product code
- MQF – Catheter, Assisted Reproduction
- 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.
- Recalling firm
- Fertility Technology Resources, Inc., Marietta, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0662-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile…Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance. | 09/13/2007Terminated |
| Z-0663-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | 09/13/2007Terminated |
| Z-0665-2008 | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | 09/13/2007Terminated |
| Z-0666-2008 | Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by:…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | 09/13/2007Terminated |
| Z-0667-2008 | Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | 09/13/2007Terminated |