FDA Device recall Z-0193-2017
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for genera…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for genera… 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-0193-2017 |
| 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
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(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: 64285 3/3/2014 61278 3/4/2014 62888 3/28/2014 67339 11/27/2014 64287 10/26/2015…Lot Numbers/ Expiration Dates: 64285 3/3/2014 61278 3/4/2014 62888 3/28/2014 67339 11/27/2014 64287 10/26/2015 65277 11/1/2015 64286 11/4/2015 65531 11/15/2015 65566 11/20/2015 65215 11/26/2015 70153 12/5/2015 67953 12/7/2015 71459 12/12/2015 69644 12/14/2015 69127 12/16/2015 70377 12/19/2015 67952 12/24/2015 64642 12/26/2015 68630 12/26/2015 71458 12/27/2015 64656 1/5/2016 71965 5/7/2016 72838 5/8/2016 73354 5/12/2016 71966 5/15/2016 68316 9/18/2016 71083 10/28/2016 69577 11/16/2016 71499 12/27/2016 72690 1/14/2017 72222 1/25/2017 73248 3/5/2017 73815 4/30/2017 75445 5/13/2017 75892 7/8/2017 76336 7/17/2017 78746 8/6/2017 80739 8/7/2017 76447 8/7/2017 78102 8/15/2017 78417 9/30/2017 77353 10/1/2017 78847 11/9/2017 78648 1/9/2018 78946 1/25/2018 80448 2/28/2018 |
|---|
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-0193-2017%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.