FDA Device recall Z-1269-2017
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 by Windstone Medical Packaging, citing 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 sterili….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1269-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | 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, WA |
Product
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
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.
Identifiers
| code_info | Lot number and expiration date 101418, 10/9/2019 84727, 5/25/2018 85308, 6/3/2018 85485, 8/5/2018 86644, 9/11/20…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2017%22
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