FDA Device recall Z-0190-2017
Facial Tray, Kit number PSS1558(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 Facial Tray, Kit number PSS1558(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-0190-2017 |
| 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
Facial Tray, Kit number PSS1558(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: 59208 11/3/2015 66913 11/9/2015 64949 1/1/2016 63581 1/4/2016 56990 6/19/2016 58…Lot Numbers/ Expiration Dates: 59208 11/3/2015 66913 11/9/2015 64949 1/1/2016 63581 1/4/2016 56990 6/19/2016 58800 8/22/2016 68611 9/11/2016 69745 9/17/2016 73553 1/27/2017 70679 3/22/2017 73768 4/11/2017 74539 6/19/2017 75798 9/19/2017 79480 1/2/2018 80615 2/23/2018 |
|---|
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-0190-2017%22
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