—#154154

Product

ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers: 72702 and 78567

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Windstone Medical Packaging, Inc.
Address: 1602 4th Ave N, Billings, Montana 59101-1521

Distribution

Distribution pattern: Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

Timeline

Recall initiated: 2017-03-16
Posted by FDA: 2017-04-11
Terminated: 2017-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.