Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
Enforcement
- Recall Number
- Z-1277-2017
- 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
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
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.
Lot number and expiration date 100106, 6/21/2019 100129, 9/30/2019 100132, 6/17/2019 100505, 10/6/2019 100805, 9/21/2019 85140, 7/28/2018 86315, 11/19/2018 87053, 9/12/2018 87623, 8/10/2019 87945, 10/29/2018 88185, 12/1/2018 88827, 10/10/2018 89726, 12/10/2018 94942, 1/10/2019 96754, 5/20/2019 97548, 5/19/2019 98079, 6/1/2019 98319, 6/24/2019 99056, 6/27/2019 99157, 6/15/2019 99711, 9/4/2019
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.
369 kits