Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
FDA Recall Z-0663-2008 · Posted 2008-01-19
Recalling FirmFertility Technology Resources, Inc.
Recall StatusTerminated
Product CodeMQF
Date Initiated2007-09-13
Date Terminated2008-02-06
Product Quantitynot reported
Reason for Recall
Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
Firm 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.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.