Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tucker Embryo Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Tucker Embryo Catheter see related information
Date Initiated by Firm September 13, 2007
Date Posted January 19, 2008
Recall Status1 Terminated 3 on February 06, 2008
Recall Number Z-0662-2008
Recall Event ID 45413
510(K)Number K023017  
Product Classification Assisted Reproduction Catheters - Product Code MQF
Product Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, 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.
510(K) Database 510(K)s with Product Code = MQF and Original Applicant = FERTILITY TECHNOLOGY RESOURCES, INC.
-
-