Recall Z-0667-2008 ยท MQF Catheter, Assisted Reproduction
Fertility Technology Resources, Inc.
Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, 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
This recall record lists no 510(k) number.