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U.S. Department of Health and Human Services

Class 2 Device Recall Tucker Embryo Catheter

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 Class 2 Device Recall Tucker Embryo Cathetersee related information
Date Initiated by FirmSeptember 13, 2007
Date PostedJanuary 19, 2008
Recall Status1 Terminated 3 on February 06, 2008
Recall NumberZ-0664-2008
Recall Event ID 45413
Product Classification Assisted Reproduction Catheters - Product Code MQF
ProductTucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, 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 ContactGeorge 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
ActionAll 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 Commercenot reported
DistributionWorldwide: 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 CycleTPLC 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.
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