FDA Device recall Z-0194-2017
General Pack I, Kit number CMP1811(B 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 Pack I, Kit number CMP1811(B 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-0194-2017 |
| 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 Pack I, Kit number CMP1811(B 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: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015…Lot Numbers/Expiration Dates: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015 65936 11/2/2015 61362 11/7/2015 62976 11/8/2015 65432 11/8/2015 66398 11/10/2015 61093 11/15/2015 62301 11/18/2015 62676 12/14/2015 64312 1/6/2016 64793 1/12/2016 64183 1/14/2016 63524 1/17/2016 57212 6/16/2016 57213 7/5/2016 67910 7/15/2016 67594 7/27/2016 58074 8/7/2016 58649 8/30/2016 70167 9/15/2016 67911 9/18/2016 68879 10/9/2016 69319 10/31/2016 |
|---|
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-0194-2017%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.