FDA Device recall Z-0182-2017
ENT Tray, Kit number AMS1195(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 ENT Tray, Kit number AMS1195(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-0182-2017 |
| 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
ENT Tray, Kit number AMS1195(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: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015…Lot Numbers/ Expiration Dates: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015 65916 11/1/2015 65449 11/2/2015 62451 11/6/2015 65563 11/9/2015 63498 11/11/2015 66317 11/12/2015 66528 11/27/2015 62114 11/30/2015 64157 1/7/2016 63818 1/24/2016 68366 7/12/2016 67034 7/15/2016 57296 7/25/2016 78780 7/30/2016 66529 8/26/2016 59011 8/28/2016 69786 9/7/2016 70822 9/13/2016 69209 10/10/2016 71824 12/10/2016 72548 1/17/2017 72194 1/31/2017 73166 3/7/2017 73705 4/2/2017 74465 5/7/2017 74906 5/30/2017 75575 7/3/2017 75725 7/8/2017 76499 7/21/2017 75890 7/29/2017 79088 9/27/2017 76846 10/5/2017 |
|---|
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-0182-2017%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.