FDA Device recall Z-0221-2017
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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 Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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-0221-2017 |
| 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
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015…Lot numbers/Expiration dates: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015 63414 1/30/2016 66908 11/26/2015 67932 4/9/2016 68546 6/11/2016 71757 9/7/2016 72106 9/2/2016 72622 8/25/2016 73283 8/5/2016 73423 8/13/2016 73765 8/2/2016 74067 8/16/2016 74310 12/8/2016 75360 2/4/2017 |
|---|
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-0221-2017%22
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