| Class 2 Device Recall Tucker Embryo Catheter | |
Date Initiated by Firm | September 13, 2007 |
Date Posted | January 19, 2008 |
Recall Status1 |
Terminated 3 on February 06, 2008 |
Recall Number | Z-0665-2008 |
Recall Event ID |
45413 |
Product Classification |
Assisted Reproduction Catheters - Product Code MQF
|
Product | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062 |
Code Information |
All units shipped before August 17, 2007 |
Recalling Firm/ Manufacturer |
Fertility Technology Resources, Inc. 4343 Shallowford Rd Ste D-4 Marietta GA 30062
|
For Additional Information Contact | George Ausman 770-641-9487 |
Manufacturer Reason for Recall | Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|