RecallRadar

FDA Device recall Z-0243-2017

Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room

On 2016-10-26 the FDA classified a Class II recall of Minor Tray AMS2685 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

AgencyFDA Device
Recall numberZ-0243-2017
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2016-10-26
Last updated2026-09-13 11:54 UTC
CompanyWindstone Medical Packaging
DistributionUS

Product

Minor Tray AMS2685 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: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952…Lot Numbers/Expiration Dates: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952 3/12/2017 73688 4/5/2017 73599 4/20/2017 74550 5/7/2017 74782 5/22/2017 75650 7/29/2017 80441 8/9/2017 78329 9/23/2017 76679 10/4/2017 78742 1/4/2018

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-0243-2017%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.