Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
- Recall Initiated
- March 16, 2017
- Posted
- April 11, 2017
- Terminated
- June 6, 2017
- Recall Number
- Z-1792-2017
- Quantity
- 260 kits
- Firm Location
- Billings, MT
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.
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Lot / Code Info
Lot numbers: 100960 103358 79099 81317 82664 82900 85028 86965 88297 89067 89311 94809 95531 98618 99932
Root Cause
Nonconforming Material/Component
Action Taken
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 vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.