FDA Device recall Z-0252-2017
Open Procedure Pack II, Kit number RMS1740(A 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 Open Procedure Pack II, Kit number RMS1740(A 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-0252-2017 |
| 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
Open Procedure Pack II, Kit number RMS1740(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: 59942 4/3/2015 59692 4/19/2015 59858 11/25/2015 65398 11/30/2015 66543 7/4/2016…Lot Numbers/ Expiration Dates: 59942 4/3/2015 59692 4/19/2015 59858 11/25/2015 65398 11/30/2015 66543 7/4/2016 67496 9/14/2016 70943 1/31/2017 70944 8/11/2017 79014 9/17/2017 79771 1/10/2018 |
|---|
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-0252-2017%22
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