Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
This recall has been terminated (originally issued February 16, 2011).
- Company
- Aspen Surgical Products, Inc.
- Recall Initiated
- December 23, 2010
- Posted
- February 16, 2011
- Terminated
- October 7, 2011
- Recall Number
- Z-1337-2011
- Quantity
- 77850 all products
- Firm Location
- Caledonia, MI
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Lot / Code Info
2010-12-09, 2013-02-23, 2013-08-12, 2013-09-24.
Root Cause
Component design/selection
Action Taken
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.