FDA Device recall Z-0197-2017
General Plastics Pack, Kit number 008617-1 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 Plastics Pack, Kit number 008617-1 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-0197-2017 |
| 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 Plastics Pack, Kit number 008617-1 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: 60558 11/6/2014 58503 11/9/2014 58887 11/15/2014 61480 11/21/2014 61881 5/16/2015…Lot Numbers/Expiration Dates: 60558 11/6/2014 58503 11/9/2014 58887 11/15/2014 61480 11/21/2014 61881 5/16/2015 62122 5/25/2015 72125 3/12/2016 56859 5/22/2016 57574 6/26/2016 75367 10/18/2016 78105 10/20/2016 72126 10/21/2016 73669 10/23/2016 74705 10/23/2016 72127 10/27/2016 76745 4/2/2017 75824 4/23/2017 79786 8/6/2017 |
|---|
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-0197-2017%22
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