FDA Device recall Z-1307-2017
General Plastics Pack, part number 008617-1
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of General Plastics Pack, part number 008617-1 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-1307-2017 |
| 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
General Plastics Pack, part number 008617-1
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 85096, 12/11/2017 85458, 12/20/2017 88364, 12/27/2017 89172, 9/3/2018 95260, 9/20…Lot number and expiration date 85096, 12/11/2017 85458, 12/20/2017 88364, 12/27/2017 89172, 9/3/2018 95260, 9/20/2018 95790, 9/9/2018 96288, 9/18/2018 96562, 9/20/2018 97526, 9/27/2018 97560, 9/13/2018 99232, 2/1/2019 99232, 2/1/2019 |
|---|
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-1307-2017%22
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