FDA Enforcement
Class II
Terminated
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
Recall: Z-1370-2017
·
Reported March 8, 2017
Enforcement
- Recall Number
- Z-1370-2017
- Event ID
- 76280
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Windstone Medical Packaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- March 8, 2017
- Initiation Date
- January 11, 2017
- Classification Date
- February 28, 2017
- Termination Date
- May 3, 2017
- Address
- 1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States
Description
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
Reason
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.
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
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.
Quantity
286 kits