FDA Device recall Z-0168-2017
Custom Venous Kit, TVS4024(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 Custom Venous Kit, TVS4024(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-0168-2017 |
| 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
Custom Venous Kit, TVS4024(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 Numbers Expiration Dates 57411 5/13/2015 58475 5/14/2015 57820 5/17/2015 60799 8/3/2015 62975 11/14/2015 6310…Lot Numbers Expiration Dates 57411 5/13/2015 58475 5/14/2015 57820 5/17/2015 60799 8/3/2015 62975 11/14/2015 63103 11/14/2015 62235 11/15/2015 62675 11/25/2015 65935 11/27/2015 60995 11/29/2015 63104 12/14/2015 64487 1/5/2016 63521 1/29/2016 67570 4/30/2016 68694 7/11/2016 69235 7/14/2016 68935 7/18/2016 67788 7/30/2016 70949 9/19/2016 76072 11/2/2016 80515 11/2/2016 74746 11/9/2016 76638 11/25/2016 73892 11/26/2016 75428 11/28/2016 79295 11/30/2016 71620 12/12/2016 70720 1/4/2017 75219 5/31/2017 77663 6/19/2017 78672 8/22/2017 |
|---|
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-0168-2017%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.