FDA Device recall Z-0154-2017
Body Contour Pack, Kit part number PSS1749 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 Body Contour Pack, Kit part number PSS1749 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-0154-2017 |
| 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
Body Contour Pack, Kit part number PSS1749 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: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 6…Lot Numbers/Expiration Dates: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 64597 1/6/2016 65800 11/5/2015 70762 10/25/2016 72336 12/9/2016 72759 1/24/2017 73439 1/27/2017 74083 4/25/2017 75079 6/25/2016 77743 9/17/2017 80762 8/2/2017 |
|---|
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-0154-2017%22
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