FDA Device recall Z-1315-2017
Hernia Pack, part number AMS3859
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Hernia Pack, part number AMS3859 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-1315-2017 |
| 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
Hernia Pack, part number AMS3859
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 101167, 5/30/2019 87349, 6/20/2018 88830, 9/11/2018 89510, 11/29/2018 94616, 11/1…Lot number and expiration date 101167, 5/30/2019 87349, 6/20/2018 88830, 9/11/2018 89510, 11/29/2018 94616, 11/15/2018 94704, 11/24/2018 95209,11/25/2018 95934, 1/15/2019 97409, 3/6/2019 99486, 3/12/2019 |
|---|
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-1315-2017%22
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