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U.S. Department of Health and Human Services

Class 2 Device Recall Weck EFx Classic Fascial Closure System

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  Class 2 Device Recall Weck EFx Classic Fascial Closure System see related information
Date Initiated by Firm March 24, 2016
Create Date August 15, 2016
Recall Status1 Terminated 3 on September 25, 2020
Recall Number Z-2538-2016
Recall Event ID 74683
Product Classification Instrument, ligature passing and knot tying - Product Code HCF
Product Weck EFx Classic Fascial Closure System, Rx Only, Sterile,
The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
Code Information Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Alice Harper
610-378-0131
Manufacturer Reason
for Recall		 Incorrect expiration date was printed on the product label.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in Commerce 45
Distribution Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
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.
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