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Baxter Healthcare Corporation Recall 90061

Description: In-Line ventilator adaptor

Baxter Healthcare Corporation Recall 90061 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1138-2022
Event ID90061
Event DescriptionIn-Line ventilator adaptor
Product TypeDevices
DistributionUS Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
Quantity259 units
Recall ReasonThere is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Device Classification20220608
Device Code InfoM08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.
Center Classification Date20220530
Recall Initiation Date20220426
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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