Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
This recall has been terminated (originally issued February 28, 2017).
- Recall Initiated
- January 11, 2017
- Posted
- February 28, 2017
- Terminated
- May 3, 2017
- Recall Number
- Z-1370-2017
- Quantity
- 286 kits
- Firm Location
- Billings, MT
- Official Source
- View on FDA website ↗
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 100932, 1/28/2018 101802, 11/13/2018 84360, 6/3/2017 85663, 7/20/2017 86544, 7/4/2017 87130, 8/24/2017 87382, 10/31/2017 87650, 9/9/2017 87669, 8/6/2017 88935, 11/11/2017 94580, 2/18/2017 97848, 12/11/2017
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.