Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
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-1319-2017
- Quantity
- 130 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 100452, 9/8/2019 100934, 10/6/2019 84549, 5/10/2018 86945, 3/9/2019 95425, 5/20/2019 99399, 6/16/2019 99741, 9/25/2019
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.