FDA Device recall Z-0263-2017
Plastic Pack , Kit number AMS1833(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 Plastic Pack , Kit number AMS1833(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-0263-2017 |
| 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
Plastic Pack , Kit number AMS1833(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 Number/ Expiration Date: 58987 3/10/2014 65124 6/13/2014 63594 6/30/2014 65383 7/3/2014 67936 9/16/2014 686…Lot Number/ Expiration Date: 58987 3/10/2014 65124 6/13/2014 63594 6/30/2014 65383 7/3/2014 67936 9/16/2014 68657 9/20/2014 67280 9/27/2014 76180 6/10/2016 57602 6/18/2016 78529 7/30/2016 59242 8/27/2016 80645 11/19/2016 |
|---|
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-0263-2017%22
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