FDA Device recall Z-0249-2017
Newport Coast Basic Pack, Kit number 007484-1 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 Newport Coast Basic Pack, Kit number 007484-1 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-0249-2017 |
| 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
Newport Coast Basic Pack, Kit number 007484-1 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: 59310 7/9/2015 63339 11/11/2015 61486 11/27/2015 65400 11/30/2015 65399 12/26/201…Lot Numbers/ Expiration Dates: 59310 7/9/2015 63339 11/11/2015 61486 11/27/2015 65400 11/30/2015 65399 12/26/2015 67044 4/5/2016 67905 5/13/2016 75637 6/25/2016 74959 8/5/2016 71107 8/11/2016 71635 8/29/2016 74764 1/15/2017 78706 9/26/2017 |
|---|
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-0249-2017%22
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