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U.S. Department of Health and Human Services

Class 2 Device Recall Weck Electrosurgical Coagulation Suction Tube 6

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  Class 2 Device Recall Weck Electrosurgical Coagulation Suction Tube 6 see related information
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
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
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
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 = GEI and Original Applicant = ALTO DEVELOPMENT CORP.
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