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U.S. Department of Health and Human Services

Class 2 Device Recall DermaHood Neuro Elastic Retractors

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  Class 2 Device Recall DermaHood Neuro Elastic Retractors see related information
Date Initiated by Firm December 06, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on May 20, 2014
Recall Number Z-0678-2012
Recall Event ID 60619
Product Classification Hook, surgical, general & plastic surgery - Product Code GDG
Product Weck, DermaHook ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809.

For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.
Code Information Catalog number: 382805, Lot numbers: 01A1100470, 01A1100374, 01A1100517, 01A1100519, 01B1100006, 01B1100131, 01B1100159, 01B1100275, 01E1000026, 01F1000586, 01G1000137, 01G1000139, 01G1000251, 01G1000326, 01H1000271,  01H1000296, 01J1000267, 01J1000298, 01K1000005, 01K1000051, 01K1000181, 01K1000334, 01L1000282, 01L1000283, 01L1000292, 01M1000008, 01M1000144, 01M1000198, 01M1000199 and 01M1000200. 
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Robert Phillips
610-572-8014
Manufacturer Reason
for Recall		 Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce to be obtained
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.
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