FDA Device recall Z-0243-2017
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room by Windstone Medical Packaging, citing the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0243-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-22 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Reason
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Identifiers
| code_info | Lot Numbers/Expiration Dates: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952…Lot Numbers/Expiration Dates: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952 3/12/2017 73688 4/5/2017 73599 4/20/2017 74550 5/7/2017 74782 5/22/2017 75650 7/29/2017 80441 8/9/2017 78329 9/23/2017 76679 10/4/2017 78742 1/4/2018 |
|---|
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-0243-2017%22
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