|
Class 2 Device Recall Sutures, Absorbable, Synthetic, Polyglycolic Acid. |
|
Date Initiated by Firm |
March 11, 2014 |
Date Posted |
March 26, 2014 |
Recall Status1 |
Terminated 3 on August 15, 2017 |
Recall Number |
Z-1294-2014 |
Recall Event ID |
67733 |
510(K)Number |
K021019
|
Product Classification |
Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
|
Product |
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only,
Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. |
Code Information |
Product Code: BON100, Lot numbers: 02H1302839, 02J1101705, 02D1101137, and 02F1103013. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr. Research Triangle Park NC 27709
|
For Additional Information Contact |
Michael T. Taggart 919-433-4940
|
Manufacturer Reason for Recall |
The products are being recalled because they did not meet minimum needle attachment strength requirements.
|
FDA Determined Cause 2 |
Employee error |
Action |
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990 |
Quantity in Commerce |
Total 32,271 ea. |
Distribution |
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland |
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 = GAT and Original Applicant = GENZYME CORP.
|
|
|
|