RecallRadar

FDA Device recall Z-1265-2017

Basic Face Kit, part number PS517A(D

On 2017-03-08 the FDA classified a Class II recall of Basic Face Kit, part number PS517A(D 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

AgencyFDA Device
Recall numberZ-1265-2017
ClassificationClass II
Statusterminated
Initiated2017-01-11
Published2017-03-08
Last updated2026-09-13 11:54 UTC
CompanyWindstone Medical Packaging
DistributionAZ, 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

Basic Face Kit, part number PS517A(D

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 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/20…Lot number and expiration date 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/2018 86370, 8/1/2018 86729, 12/26/2018 89108, 11/15/2018 89302, 12/25/2018 89652, 11/19/2018 94627, 1/11/2019 95899, 5/21/2019 96504, 5/5/2019 97666, 6/26/2019 97832, 6/13/2019 99264, 9/3/2019

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-1265-2017%22

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