FDA Device recall Z-0258-2017
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D 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 Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D 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-0258-2017 |
| 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
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(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: 56901 1/31/2015 57410 5/13/2015 57819 5/25/2015 58770 7/19/2015 59874 8/14/2015…Lot Numbers/ Expiration Dates: 56901 1/31/2015 57410 5/13/2015 57819 5/25/2015 58770 7/19/2015 59874 8/14/2015 60612 10/10/2015 61900 11/6/2015 62135 11/13/2015 64254 11/16/2015 65934 11/18/2015 63855 1/2/2016 64311 1/5/2016 68002 7/12/2016 73542 1/3/2017 74101 1/9/2017 77040 3/11/2017 75746 3/15/2017 78275 3/23/2017 78671 9/10/2017 80514 11/27/2017 |
|---|
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-0258-2017%22
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