FDA Device recall Z-1285-2017
Custom Pack - with Introducer Kit, part number TVS4011NI(L
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Custom Pack - with Introducer Kit, part number TVS4011NI(L 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-1285-2017 |
| 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
Custom Pack - with Introducer Kit, part number TVS4011NI(L
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 85014, 4/30/2018 85448, 7/14/2018 85937, 8/23/2018 87713, 8/9/2018 88092, 11/18/2…Lot number and expiration date 85014, 4/30/2018 85448, 7/14/2018 85937, 8/23/2018 87713, 8/9/2018 88092, 11/18/2018 89342, 10/17/2018 89974, 12/5/2018 95212, 12/3/2018 95725, 12/19/2018 96882, 12/9/2018 97051, 5/27/2019 98088, 5/2/2019 98423, 5/25/2019 98852, 5/14/2019 |
|---|
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-1285-2017%22
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