FDA Device recall Z-0242-2017
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general sur…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general sur… 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-0242-2017 |
| 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 Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(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: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 6…Lot Numbers/Expiration Dates: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 65729 11/15/2015 65371 11/18/2015 62925 11/26/2015 64759 12/26/2015 63807 1/14/2016 64511 1/16/2016 65907 7/11/2016 57777 7/16/2016 67561 8/26/2016 69460 9/11/2016 69554 11/9/2016 72302 1/5/2017 71984 1/27/2017 73801 4/2/2017 74579 4/23/2017 78211 4/26/2017 74831 5/23/2017 74685 5/24/2017 74462 5/25/2017 74578 5/26/2017 75514 7/2/2017 77373 7/19/2017 78511 8/6/2017 75602 9/19/2017 79095 11/4/2017 79588 11/20/2017 79682 1/17/2018 79251 1/26/2018 81260 2/13/2018 80649 2/27/2018 |
|---|
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-0242-2017%22
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