FDA Device recall Z-0264-2017
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C 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 Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C 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-0264-2017 |
| 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
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C 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 Number/ Expiration Date: 63877 2/4/2015 65406 2/26/2015 65972 2/26/2015 64947 10/18/2015 61767 11/13/2015 6…Lot Number/ Expiration Date: 63877 2/4/2015 65406 2/26/2015 65972 2/26/2015 64947 10/18/2015 61767 11/13/2015 64379 1/4/2016 63309 1/22/2016 57497 7/1/2016 67411 7/11/2016 58086 7/19/2016 77189 7/30/2016 68577 9/22/2016 69473 10/17/2016 72803 1/16/2017 72989 3/29/2017 73422 4/16/2017 76920 4/23/2017 73577 4/25/2017 74415 5/9/2017 74835 6/18/2017 76482 7/13/2017 |
|---|
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-0264-2017%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.