| Class 2 Device Recall Safety Laceration Kit | |
Date Initiated by Firm | June 12, 2014 |
Date Posted | July 01, 2014 |
Recall Status1 |
Terminated 3 on February 03, 2015 |
Recall Number | Z-1955-2014 |
Recall Event ID |
68564 |
Product Classification |
Suture kit - Product Code OVN
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Product | Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. |
Code Information |
Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017. |
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 |
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 |
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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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