FDA Device recall Z-1265-2017
Basic Face Kit, part number PS517A(D
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Basic Face Kit, part number PS517A(D 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-1265-2017 |
| 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 Face Kit, part number PS517A(D
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 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/20…Lot number and expiration date 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/2018 86370, 8/1/2018 86729, 12/26/2018 89108, 11/15/2018 89302, 12/25/2018 89652, 11/19/2018 94627, 1/11/2019 95899, 5/21/2019 96504, 5/5/2019 97666, 6/26/2019 97832, 6/13/2019 99264, 9/3/2019 |
|---|
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-1265-2017%22
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