FDA Device recall Z-0198-2017
General Surgery Pack, Kit number PSS1380(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 General Surgery Pack, Kit number PSS1380(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-0198-2017 |
| 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
General Surgery Pack, Kit number PSS1380(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: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015…Lot Numbers/ Expiration Dates: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 1/9/2018 |
|---|
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-0198-2017%22
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