FDA Device recall Z-0278-2017
Transvaginal Pack, Kit number CMP1767 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 Transvaginal Pack, Kit number CMP1767 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-0278-2017 |
| 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
Transvaginal Pack, Kit number CMP1767 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 Number/ Expiration Date: 59178 4/13/2015 59934 7/12/2015 65288 11/2/2015 62926 11/10/2015 61866 11/11/2015…Lot Number/ Expiration Date: 59178 4/13/2015 59934 7/12/2015 65288 11/2/2015 62926 11/10/2015 61866 11/11/2015 66049 11/15/2015 62393 11/28/2015 65692 12/22/2015 63808 1/6/2016 64452 1/17/2016 57606 6/7/2016 66520 7/23/2016 57779 8/10/2016 69057 9/3/2016 59004 9/11/2016 67872 9/30/2016 60067 12/27/2016 69452 1/3/2017 72635 1/9/2017 72687 1/17/2017 72841 3/9/2017 72688 3/22/2017 73048 5/21/2017 74873 5/24/2017 74988 7/16/2017 76993 8/14/2017 77250 9/11/2017 80477 1/9/2018 77808 1/16/2018 67027 (no date was provided) |
|---|
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-0278-2017%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.