FDA Device recall Z-0246-2017
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A 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 Morris Hysto Pack, Kit number PSS3198 and PSS3198(A 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-0246-2017 |
| 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
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A 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: 65959 12/25/2015 68013 8/9/2016 69749 11/23/2016 71891 12/18/2016 70206 1/5/2017…Lot Numbers/ Expiration Dates: 65959 12/25/2015 68013 8/9/2016 69749 11/23/2016 71891 12/18/2016 70206 1/5/2017 72293 1/7/2017 72801 5/24/2017 74795 7/30/2017 79807 8/1/2017 76757 10/25/2017 |
|---|
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-0246-2017%22
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