FDA Device recall Z-0284-2017
Virginia Custom Pack, Kit number RMS1744 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 Virginia Custom Pack, Kit number RMS1744 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-0284-2017 |
| 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
Virginia Custom Pack, Kit number RMS1744 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: 59798 9/26/2014 59796 7/5/2015 59797 7/5/2015 61329 7/5/2015 60411 8/5/2015 6122…Lot Numbers/ Expiration Dates: 59798 9/26/2014 59796 7/5/2015 59797 7/5/2015 61329 7/5/2015 60411 8/5/2015 61222 9/1/2015 60758 9/9/2015 66544 11/5/2015 66261 11/7/2015 64654 11/8/2015 61679 11/9/2015 63209 11/13/2015 62471 11/17/2015 61678 11/27/2015 65932 11/30/2015 62470 12/9/2015 63208 12/18/2015 63927 1/5/2016 64653 1/7/2016 64307 1/18/2016 63926 1/20/2016 68195 7/5/2016 68638 7/7/2016 67670 7/16/2016 66545 7/23/2016 69868 9/15/2016 69907 9/17/2016 68874 9/25/2016 70705 10/25/2016 69039 10/27/2016 70945 12/5/2016 70704 1/4/2017 71513 1/27/2017 71688 3/6/2017 71840 3/6/2017 73729 4/17/2017 73177 4/20/2017 73393 4/21/2017 73731 5/16/2017 74648 5/30/2017 75024 7/3/2017 75160 7/11/2017 75975 7/21/2017 76242 8/3/2017 76441 8/18/2017 77269 8/22/2017 78308 9/26/2017 77268 10/8/2017 78593 11/4/2017 79038 11/20/2017 79881 1/7/2018 79039 2/28/2018 |
|---|
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-0284-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.