—#152791

Product

Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers and Expiration Dates 83622, 5/19/2018 84374, 5/24/2018 84729, 5/17/2017 84897, 5/26/2018 84946, 6/24/2017 85171, 6/9/2018 85363, 7/20/2017 85548, 7/15/2018 85696, 8/22/2018 85698, 7/21/2017 86510, 9/29/2018 86687, 9/5/2018 86889, 7/11/2017 86909, 9/12/2018 87156, 8/1/2018 87157, 9/5/2018 87159, 10/23/2017 87289, 10/17/2017 87978, 10/31/2017 88401, 10/7/2017 88549, 10/28/2017 88656, 12/7/2017 89219, 12/22/2017 89904, 1/23/2017 94742, 12/29/2017 95143, 12/4/2017 95284, 2/2/2018 95315, 2/20/2018 95840, 2/13/2018 96006, 1/7/2018 96469, 2/27/2018 96631, 1/8/2018 96821, 3/25/2018 96931, 2/1/2018 97751, 3/2/2018 98923, 3/20/2018 98971, 9/19/2018

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 #152791. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.