FDA Device recall Z-1294-2017

ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214

FDA Device
Class II
terminated
Published 2017-03-08

On 2017-03-08 the FDA classified a Class II recall of ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214 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-1294-2017
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

ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214

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 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/20… Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019

code_info

Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/20…

Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019

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-1294-2017%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.