FDA Device recall Z-0164-2017
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital op…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital op… by Windstone Medical Packaging, citing the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0164-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-22 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Reason
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Identifiers
| code_info | Lot numbers/Expiration dates: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61…Lot numbers/Expiration dates: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61743 7/21/2014 63397 12/21/2014 63273 12/26/2014 64371 3/13/2015 64329 3/21/2015 66935 4/22/2015 67471 5/11/2015 68296 9/19/2015 68614 9/27/2015 68614 9/27/2015 70876 10/12/2015 69816 10/14/2015 70681 10/20/2015 71211 10/21/2015 71695 10/26/2015 73064 12/20/2015 72359 12/24/2015 77377 1/19/2016 76155 1/25/2016 81170 7/8/2016 |
|---|
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-0164-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.