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U.S. Department of Health and Human Services

Class 2 Device Recall Suture Set

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  Class 2 Device Recall Suture Set see related information
Date Initiated by Firm June 12, 2014
Date Posted July 01, 2014
Recall Status1 Terminated 3 on February 03, 2015
Recall Number Z-1952-2014
Recall Event ID 68564
Product Classification Suture kit - Product Code OVN
Product Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Code Information Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.
Recalling Firm/
Manufacturer		 Medical Action Industries Inc
25 Heywood Rd
Arden NC 28704-9302
For Additional Information Contact Larry D. Bogues
757-566-3510 Ext. 9315
Manufacturer Reason
for Recall		 Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
Quantity in Commerce 474 cs (9,480 ea) total for all kits involved
Distribution Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
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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