FDA Device recall Z-0180-2017
Endoscopy Pack, Kit number PSS1646 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 Endoscopy Pack, Kit number PSS1646 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-0180-2017 |
| 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
Endoscopy Pack, Kit number PSS1646 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: 59053 3/28/2015 77459 9/11/2015 65230 10/26/2015 60259 10/27/2015 61170 11/14/2015…Lot numbers/Expiration dates: 59053 3/28/2015 77459 9/11/2015 65230 10/26/2015 60259 10/27/2015 61170 11/14/2015 66914 11/26/2015 64387 1/11/2016 63883 1/25/2016 57221 6/19/2016 57956 7/20/2016 77460 7/30/2016 69800 9/6/2016 70560 12/3/2016 72104 1/1/2017 72585 4/19/2017 |
|---|
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-0180-2017%22
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