FDA Device recall Z-1366-2017
Set Up Pack, part number PSS3574(A
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Set Up Pack, part number PSS3574(A by Windstone Medical Packaging, citing the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterili….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1366-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, WA |
Product
Set Up Pack, part number PSS3574(A
Reason
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Identifiers
| code_info | Lot number and expiration date 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/201…Lot number and expiration date 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/2018 86927, 7/16/2018 87263, 10/10/2018 89647, 11/23/2018 89913, 10/2/2018 94889, 11/28/2018 95156, 11/14/2018 95674, 12/27/2018 96088, 1/25/2019 96849, 3/7/2019 96990, 5/7/2019 97637, 5/27/2019 98073, 5/23/2019 98373, 5/30/2019 99444, 6/24/2019 |
|---|
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-1366-2017%22
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