RecallRadar

FDA Device recall Z-1317-2017

HSG Pack, part number PSS3287

On 2017-03-08 the FDA classified a Class II recall of HSG Pack, part number PSS3287 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-1317-2017
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

HSG Pack, part number PSS3287

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_infoLot number and expiration date 86441, 8/16/2018 87951, 12/1/2018 89639, 12/29/2018 94599, 1/21/2019 94870, 11/19/2018 99799, 10/7/2019

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-1317-2017%22

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