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U.S. Department of Health and Human Services

Class 2 Device Recall Viscot Corneal Marking Pad, Sterile

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  Class 2 Device Recall Viscot Corneal Marking Pad, Sterile see related information
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
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
For Additional Information Contact Kelli Jonas
616-698-7100
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.
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
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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