FDA Device recall Z-0231-2017
Major General Pack, Kit number 002645-11 and 002645-12 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 Major General Pack, Kit number 002645-11 and 002645-12 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-0231-2017 |
| 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
Major General Pack, Kit number 002645-11 and 002645-12 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 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 6…Lot Numbers Expiration Dates 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 60645 1/13/2014 59179 1/14/2014 67196 1/31/2014 65990 2/28/2014 63190 9/15/2014 62540 9/20/2014 67875 9/28/2014 65484 9/30/2014 69395 5/2/2016 56674 5/29/2016 71054 6/3/2016 57460 6/14/2016 68944 6/20/2016 70475 8/10/2016 |
|---|
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-0231-2017%22
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