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Recall Observatory FDA recall evidence

Device product

In-Line ventilator adaptor

Z-1138-2022

April 26, 2022

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90061
Status
Terminated
Classification
Class I
Quantity
259 units
Official record key
device-enforcement:Z-1138-2022

Official wording

Reason: There 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.

Code information: M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.

Distribution pattern: US 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There 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.