FDA Device recall Z-0148-2017
Basic Setup Pack, kit part number AMS1787(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 Basic Setup Pack, kit part number AMS1787(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-0148-2017 |
| 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
Basic Setup Pack, kit part number AMS1787(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 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 6999…Lot Numbers Expiration Dates 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 69999 10/2/2016 70654 10/11/2016 71789 12/10/2016 72154 3/8/2017 73836 5/16/2017 75272 7/18/2017 76643 7/1/2017 77304 10/8/2017 78543 8/30/2017 |
|---|
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-0148-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.