—#152883

Product

Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(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 84903, 7/25/2018 85836, 8/22/2018 86720, 9/30/2018 86873, 8/16/2018 87104, 8/30/2018 88049, 10/29/2018 88170, 10/5/2018 88378, 11/15/2018 88379, 12/2/2018 89576, 11/15/2018 89577, 12/2/2018 89721, 12/17/2018 94931, 1/29/2019 94932, 1/5/2019 95274, 1/27/2019 95596, 1/13/2019 95983, 6/10/2019 96593, 5/1/2019 97448, 5/28/2019 97653, 6/17/2019 97654, 6/24/2019 97655, 6/21/2019

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 #152883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.