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Class 2 Device Recall Viscot Corneal Marking Pad, Sterile |
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Date Initiated by Firm |
December 23, 2010 |
Date Posted |
February 16, 2011 |
Recall Status1 |
Terminated 3 on October 07, 2011 |
Recall Number |
Z-1339-2011 |
Recall Event ID |
57792 |
Product Classification |
Corneal Marking Pad - Product Code HMR
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Product |
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery. |
Code Information |
2010-10-14, 2010-12-02, 2012-02-03, 2012-03-17, 2012-04-14, 2012-06-23, 2012-07-20, 2012-10-12, 2012-11-30, 2013-03-12, 2013-04-08, 2013-04-22, 2013-07-28, 2013-09-01. |
Recalling Firm/ Manufacturer |
Aspen Surgical Products, Inc. 6945 Southbelt Dr Se Caledonia MI 49316-7664
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For Additional Information Contact |
Kelli Jonas 616-698-7100
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Manufacturer Reason for Recall |
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers.
The firm does not intend to continue manufacturing or distributing the product. |
Quantity in Commerce |
77850 all products |
Distribution |
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel. |
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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