FDA Device recall Z-0145-2017
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating r…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating r… 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-0145-2017 |
| 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 Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. 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: 57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 5997…Lot Numbers/Expiration Dates: 57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 59975 7/18/2015 60444 9/13/2015 60705 8/3/2015 61043 8/20/2015 61552 11/27/2015 62834 11/7/2015 63155 11/27/2015 63156 1/2/2016 64068 11/23/2015 64504 11/10/2015 65556 11/9/2015 65855 11/6/2015 66687 11/26/2015 67232 11/18/2015 67233 8/10/2016 67579 8/22/2016 68618 7/11/2016 68940 9/12/2016 69988 9/23/2016 71297 9/12/2016 71430 12/25/2016 71814 12/13/2016 72034 3/13/2017 73741 4/3/2017 74154 4/26/2017 74893 5/4/2017 75440 5/14/2017 75692 7/12/2017 76228 7/3/2017 76544 7/29/2017 76710 8/29/2017 77124 9/23/2017 79188 9/16/2017 79450 1/9/2018 79755 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-0145-2017%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.