FDA Device recall Z-0215-2017
Lap Band Pack, Kit number AMS1785(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 Lap Band Pack, Kit number AMS1785(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-0215-2017 |
| 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
Lap Band Pack, Kit number AMS1785(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 numbers/Expiration dates: 58289 10/17/2014 60644 2/19/2015 65363 2/28/2015 61474 7/23/2015 65877 11/1/2015…Lot numbers/Expiration dates: 58289 10/17/2014 60644 2/19/2015 65363 2/28/2015 61474 7/23/2015 65877 11/1/2015 64537 11/30/2015 66998 1/31/2016 68952 1/31/2016 67661 2/29/2016 71625 2/29/2016 70410 4/30/2016 71947 5/31/2016 72877 5/31/2016 57137 6/7/2016 77238 6/30/2016 78143 6/30/2016 73985 8/31/2016 74752 8/31/2016 74973 8/31/2016 76523 8/31/2016 |
|---|
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-0215-2017%22
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