—#152905

Product

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot number and expiration date 100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018

Why it was recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 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 with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Recalling firm

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

Distribution

Distribution pattern: Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Timeline

Recall initiated: 2017-01-11
Posted by FDA: 2017-02-28
Terminated: 2017-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152905. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.