Set Up Pack, part number PSS3574(A
- Recall Initiated
- January 11, 2017
- Posted
- February 28, 2017
- Terminated
- May 3, 2017
- Recall Number
- Z-1366-2017
- Quantity
- 820 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 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/2018 86927, 7/16/2018 87263, 10/10/2018 89647, 11/23/2018 89913, 10/2/2018 94889, 11/28/2018 95156, 11/14/2018 95674, 12/27/2018 96088, 1/25/2019 96849, 3/7/2019 96990, 5/7/2019 97637, 5/27/2019 98073, 5/23/2019 98373, 5/30/2019 99444, 6/24/2019
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.