FDA Device recall Z-0208-2017
Hernia Pack, Kit number AMS1519 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 Hernia Pack, Kit number AMS1519 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-0208-2017 |
| 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
Hernia Pack, Kit number AMS1519 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: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014…Lot Numbers/ Expiration Dates: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014 64165 9/14/2014 65059 9/27/2014 67591 9/29/2014 68544 5/7/2015 68386 5/24/2015 68720 9/14/2015 70550 10/8/2015 69342 10/17/2015 74095 12/2/2015 73780 12/23/2015 76033 2/22/2016 76082 2/22/2016 72977 2/25/2016 76032 2/27/2016 56835 5/29/2016 |
|---|
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-0208-2017%22
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