Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
- Recall Initiated
- January 11, 2017
- Posted
- February 28, 2017
- Terminated
- May 3, 2017
- Recall Number
- Z-1332-2017
- Quantity
- 331 kits
- Firm Location
- Billings, MT
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Lot number and expiration date 100128, 9/28/2019 84856, 1/31/2019 86767, 12/22/2018 87491, 10/22/2017 88562, 10/20/2017 89958, 12/15/2018 94988, 12/5/2017 95849, 12/3/2017 96246, 3/3/2019 97441, 6/4/2019 97888, 6/16/2018 98626, 6/24/2019 98972, 7/22/2018 99473, 6/6/2019
Root Cause
Nonconforming Material/Component
Action Taken
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.