FDA Enforcement Class II Terminated

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A

Recall: Z-1363-2017 · Reported March 8, 2017

Enforcement

Recall Number
Z-1363-2017
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

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A

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 83685, 5/17/2018 84193, 5/20/2018 84520, 5/25/2018 84823, 6/30/2018 84892, 6/16/2018 85953, 7/29/2018 85991, 7/15/2018 85992, 7/23/2018 86060, 7/11/2018 86346, 7/30/2018 86419, 8/25/2018 87109, 8/15/2018 87789, 9/23/2018 87886, 10/29/2018 88300, 9/23/2018 88301, 9/30/2018 88313, 9/23/2018 88331, 10/11/2018 88332, 10/22/2018 88333, 10/25/2018 88630, 11/17/2018 88630, 11/17/2018 88707, 11/11/2018 88937, 6/28/2019 89028, 12/13/2018 95275, 1/19/2019 95598, 12/27/2018 95803, 1/11/2019 95989, 1/26/2019 96597, 3/24/2019 96916, 3/5/2019 97452, 3/21/2019 97580, 4/15/2019 97781, 4/22/2019 98022, 5/31/2019 98314, 5/29/2019 98668, 6/11/2019 98908, 7/24/2019 99873, 10/1/2019 99874, 6/4/2019

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

2018 kits