FDA Device recall Z-1289-2017
D&C/Cysto Pack, part number PSS3257(D
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of D&C/Cysto Pack, part number PSS3257(D 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-1289-2017 |
| 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
D&C/Cysto Pack, part number PSS3257(D
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 100086, 5/12/2019 85563, 8/13/2017 87345, 8/18/2017 89066, 8/8/2017 94998, 8/18/2…Lot number and expiration date 100086, 5/12/2019 85563, 8/13/2017 87345, 8/18/2017 89066, 8/8/2017 94998, 8/18/2017 95508, 8/12/2017 95667, 3/10/2017 96490, 8/5/2017 97900, 4/13/2019 99440, 4/5/2019 |
|---|
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-1289-2017%22
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