FDA Device recall Z-1283-2017
Custom Breast Augmentation Pack, part number PSS2455(D
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Custom Breast Augmentation Pack, part number PSS2455(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-1283-2017 |
| 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 Breast Augmentation Pack, part number PSS2455(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 100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/…Lot number and expiration date 100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/2017 89226, 5/25/2017 96139, 7/6/2017 96969, 7/30/2017 97625, 7/27/2017 |
|---|
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-1283-2017%22
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