FDA Device recall Z-0209-2017
HSG Pack, Kit number PSS3287 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 HSG Pack, Kit number PSS3287 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-0209-2017 |
| 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
HSG Pack, Kit number PSS3287 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: 67433 8/1/2016 71250 9/12/2016 69748 9/20/2016 71417 1/3/2017 72802 4/23/2017 74…Lot Numbers/ Expiration Dates: 67433 8/1/2016 71250 9/12/2016 69748 9/20/2016 71417 1/3/2017 72802 4/23/2017 74796 7/14/2017 78203 8/5/2017 76919 8/16/2017 79432 2/25/2018 |
|---|
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-0209-2017%22
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