Date Initiated by Firm | December 19, 2013 |
Date Posted | January 15, 2014 |
Recall Status1 |
Terminated 3 on May 20, 2016 |
Recall Number | Z-0770-2014 |
Recall Event ID |
67129 |
510(K)Number | K881413 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770.
Intended to remove tissue and control bleeding by use of high-frequency electrical current. |
Code Information |
Catalog Number: 809600, Lot Numbers: 01M1000201, 01A1100320, 01C1000012, 01C1000385, 01E1000392. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr. Research Triangle Park NC 27709
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For Additional Information Contact | Michael T. Taggart 919-433-4940 |
Manufacturer Reason for Recall | Sterility cannot be guaranteed. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received product. |
Quantity in Commerce | 17,450 ea. |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = GEI
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