FDA Device recall Z-0186-2017
Eye Plastic Tray, Kit number PSS1931(A 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 Eye Plastic Tray, Kit number PSS1931(A 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-0186-2017 |
| 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
Eye Plastic Tray, Kit number PSS1931(A 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 56700 2/25/2014 57515 4/17/2014 62330 8/13/2014 61942 8/29/2014 59216 10/8/2014 6301…Lot Numbers Expiration Dates 56700 2/25/2014 57515 4/17/2014 62330 8/13/2014 61942 8/29/2014 59216 10/8/2014 63015 1/2/2015 62624 1/6/2015 68055 6/9/2015 66922 6/26/2015 68289 8/28/2015 68448 10/13/2015 72101 11/18/2015 72971 2/28/2016 75676 5/16/2016 76488 9/4/2016 78162 11/13/2016 79264 1/6/2017 |
|---|
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-0186-2017%22
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