Z-1269-2017 Class II Terminated

Recalled by Windstone Medical Packaging, Inc. — Billings, MT

Recall Details

Product Type
Devices
Report Date
March 8, 2017
Initiation Date
January 11, 2017
Termination Date
May 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
276 kits

Product Description

Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519

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 Pattern

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.

Code Information

Lot number and expiration date 101418, 10/9/2019 84727, 5/25/2018 85308, 6/3/2018 85485, 8/5/2018 86644, 9/11/2018 87420, 9/14/2018 88160, 11/15/2018 89015, 10/8/2018 89570, 12/1/2018 94914, 1/21/2019 94920, 1/12/2019 95736, 1/2/2019 96290, 1/28/2019 96902, 8/16/2020 99041, 9/25/2019