RecallRadar

FDA Device recall Z-1274-2017

Bayview Breast Pack, part number 009080-2

On 2017-03-08 the FDA classified a Class II recall of Bayview Breast Pack, part number 009080-2 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-1274-2017
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

Bayview Breast Pack, part number 009080-2

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 84687, 2/24/2018 86231, 2/9/2018 89386, 4/8/2018 94891, 4/23/2018 95261, 4/12/2018 95968, 4/1/2018 96742, 4/23/2018

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-1274-2017%22

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