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Class 2 Device Recall Laceration Trays |
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Date Initiated by Firm |
June 12, 2014 |
Date Posted |
July 01, 2014 |
Recall Status1 |
Terminated 3 on February 03, 2015 |
Recall Number |
Z-1950-2014 |
Recall Event ID |
68564 |
Product Classification |
Suture kit - Product Code OVN
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Product |
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. |
Code Information |
Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018. |
Recalling Firm/ Manufacturer |
Medical Action Industries Inc 25 Heywood Rd Arden NC 28704-9302
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For Additional Information Contact |
Larry D. Bogues 757-566-3510 Ext. 9315
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Manufacturer Reason for Recall |
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
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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
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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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