FDA Device recall Z-0146-2017
Basic Kit, Part numbers BP1110(C and CMP1109(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 Basic Kit, Part numbers BP1110(C and CMP1109(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-0146-2017 |
| 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
Basic Kit, Part numbers BP1110(C and CMP1109(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: 57495 7/3/2016 57946 6/29/2016 59013 8/22/2016 59014 3/28/2015 60496 9/1/2015 618…Lot Numbers/Expiration Dates: 57495 7/3/2016 57946 6/29/2016 59013 8/22/2016 59014 3/28/2015 60496 9/1/2015 61879 11/6/2015 62950 11/28/2015 64294 1/7/2016 65396 11/3/2015 65981 11/1/2015 67215 7/16/2016 68373 9/4/2016 70215 9/15/2016 71010 10/17/2016 72059 3/21/2017 73446 3/7/2017 73960 4/5/2017 74662 5/9/2017 75137 5/5/2017 75760 7/13/2017 77133 7/17/2017 77727 8/16/2017 78449 9/15/2017 79367 1/25/2018 79939 1/17/2018 |
|---|
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-0146-2017%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.