Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Techno

FDA device recall Z-0664-2008 · posted 2008-01-19 · Terminated

Recall details

Recalling firm

Fertility Technology Resources, Inc.

Reason for recall

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

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.

Root cause

Process design

Status

Terminated

Product code

MQF

Quantity affected

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.

Date initiated

2007-09-13

Date posted

2008-01-19

Date terminated

2008-02-06

Location

Marietta, GA