FDA Device recall Z-0268-2017
Set-Up Pack, Kit number PSS1305(B and PSS1305(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 Set-Up Pack, Kit number PSS1305(B and PSS1305(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-0268-2017 |
| 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
Set-Up Pack, Kit number PSS1305(B and PSS1305(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: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 5…Lot Number/ Expiration Date: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 58345 8/14/2016 69798 9/14/2016 69922 9/16/2016 69923 9/29/2016 58346 10/4/2016 70578 10/11/2016 68747 10/12/2016 69280 10/23/2016 70579 12/5/2016 70580 12/26/2016 70988 3/23/2017 73558 4/24/2017 74320 5/24/2017 74472 5/25/2017 75989 7/16/2017 77190 7/21/2017 76466 7/22/2017 74850 7/23/2017 76890 7/23/2017 75368 7/30/2017 76891 8/4/2017 76903 8/10/2017 77517 8/29/2017 77987 9/5/2017 77361 10/10/2017 78110 1/9/2018 78111 2/6/2018 |
|---|
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-0268-2017%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.