FDA Device recall Z-0219-2017
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room 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-0219-2017 |
| 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
Laparoscopic Pack, Kit number AMS2499 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: 62086 11/7/2015 65280 11/8/2015 62087 11/17/2015 65736 11/30/2015 64547 1/6/2016…Lot numbers/Expiration dates: 62086 11/7/2015 65280 11/8/2015 62087 11/17/2015 65736 11/30/2015 64547 1/6/2016 67957 7/7/2016 67016 7/16/2016 67697 8/9/2016 69435 9/18/2016 70253 9/23/2016 70497 10/18/2016 70156 10/31/2016 70808 12/13/2016 71959 1/14/2017 73320 3/5/2017 72888 3/24/2017 73333 5/7/2017 75288 5/11/2017 76049 7/20/2017 78640 8/12/2017 78151 8/18/2017 76946 8/31/2017 77686 10/8/2017 77310 10/24/2017 69018 12/10/2017 78978 1/20/2018 |
|---|
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-0219-2017%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.