FDA Device recall Z-1354-2017
Ortho Minor Pack, part number AMS3710(A
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Ortho Minor Pack, part number AMS3710(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-1354-2017 |
| 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
Ortho Minor Pack, part number AMS3710(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 100234, 9/8/2019 84944, 6/4/2018 85366, 7/23/2018 85662, 9/29/2018 86669, 9/15/20…Lot number and expiration date 100234, 9/8/2019 84944, 6/4/2018 85366, 7/23/2018 85662, 9/29/2018 86669, 9/15/2018 87127, 11/21/2018 89042, 12/12/2018 89735, 11/12/2018 95813, 1/28/2019 96010, 1/26/2019 97466, 5/28/2019 98514, 6/30/2019 99386, 6/10/2019 |
|---|
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-1354-2017%22
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