PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
FDA Recall Z-1797-2017 · Posted 2017-04-11
Recalling FirmWindstone Medical Packaging, Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2017-03-16
Date Terminated2017-06-06
Product Quantity20 kits
Reason for Recall
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Firm Action
AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit.
Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to [email protected].
Customers can call Aligned Medical Solutions at 321-527-7714.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.