FDA Device recall Z-0178-2017
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating…
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating… 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-0178-2017 |
| 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
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C 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: 59444 7/10/2014 60056 8/8/2014 60425 8/20/2014 60967 11/3/2014 59000 1/13/2015 63…Lot Numbers/Expiration Dates: 59444 7/10/2014 60056 8/8/2014 60425 8/20/2014 60967 11/3/2014 59000 1/13/2015 63464 2/9/2015 64533 2/25/2015 61267 2/27/2015 63798 3/30/2015 65629 7/30/2015 66813 10/21/2015 69765 11/2/2015 69528 11/18/2015 67138 11/19/2015 67399 1/2/2016 67989 2/6/2016 70374 3/17/2016 69766 3/30/2016 71447 4/18/2016 72241 5/15/2016 57208 7/24/2016 75250 8/7/2016 58621 8/10/2016 73977 8/11/2016 73190 8/12/2016 73277 8/23/2016 74340 8/26/2016 78679 10/24/2016 79046 10/25/2016 75603 1/26/2017 76940 2/11/2017 76159 2/14/2017 78015 6/16/2017 76568 6/26/2017 79824 7/25/2017 81121 8/13/2017 68922 |
|---|
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-0178-2017%22
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