In-Line ventilator adaptor
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled 259 units of its Volara system in-line ventilator adaptor due to a potential risk of reduced oxygenation or pneumothorax/barotrauma when used with an in-line ventilator in home care environments. The affected product is the M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT (UDI-DI: 00887761981492) with manufacturing dates from February 28, 2020 to present, and the recall affects units distributed nationwide across 31 states including Texas, Florida, Virginia, Kentucky, California, Arizona, and others.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 259 units Lot/code info: M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.