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 TEV Sutures

  • 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 TEV Suturessee related information
Date Initiated by FirmJune 06, 2007
Date PostedJuly 17, 2007
Recall Status1 Terminated 3 on March 14, 2008
Recall NumberZ-1017-2007
Recall Event ID 38220
510(K)NumberK001434 K001440 K021019 
Product Classification Sutures - Product Code GAM
ProductVarious Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114
Code Information Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114, Lot #21486, 21487, 21488, 23468, 23469, 41910 & 55380.
Recalling Firm/
Manufacturer		 Teleflex Creek Dr
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information ContactMichael Crader
919-433-4829
Manufacturer Reason
for Recall		Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
Quantity in Commerce1920 units total for all types of sutures
DistributionWorldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
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.
510(K) Database510(K)s with Product Code = GAM
510(K)s with Product Code = GAM
-
-