RecallRadar

FDA Device recall Z-1380-2017

Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A

On 2017-03-08 the FDA classified a Class II recall of Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A 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-1380-2017
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

Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A

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 89251, 12/25/2018 89524, 10/25/2018 89601, 12/17/2018 89838, 12/17/2018 99349, 6/18/2019 99729, 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-1380-2017%22

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