FDA Device recall Z-0240-2017
Minor Lithotomy Pack, Kit number 002650-7 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 Minor Lithotomy Pack, Kit number 002650-7 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-0240-2017 |
| 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
Minor Lithotomy Pack, Kit number 002650-7 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: 66523 1/31/2014 61660 2/2/2014 61505 2/24/2014 60540 3/30/2014 67197 9/10/2014 6…Lot Numbers/ Expiration Dates: 66523 1/31/2014 61660 2/2/2014 61505 2/24/2014 60540 3/30/2014 67197 9/10/2014 65055 9/30/2014 58208 7/5/2016 68949 9/12/2016 71055 12/27/2016 |
|---|
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-0240-2017%22
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