FDA Device recall Z-0281-2017
Upper Torso Tray, Kit number PSS1554(B 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 Upper Torso Tray, Kit number PSS1554(B 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-0281-2017 |
| 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
Upper Torso Tray, Kit number PSS1554(B 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: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015…Lot Numbers/ Expiration Dates: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015 63227 7/20/2015 61936 8/28/2015 59666 10/14/2015 65111 10/20/2015 64230 11/10/2015 65410 12/11/2015 66232 5/19/2016 67772 7/9/2016 57871 7/12/2016 68610 9/20/2016 78517 9/30/2016 70880 10/28/2016 71119 12/14/2016 74426 12/24/2016 73427 1/22/2017 72781 1/30/2017 73810 3/18/2017 78127 8/18/2017 79916 9/20/2017 |
|---|
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-0281-2017%22
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