In-Line ventilator adaptor
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling the in-line ventilator adaptor for the Volara system due to a potential risk of reduced oxygenation or pneumothorax/barotrauma when used with in-line ventilators in home care environments. The recall affects 9 units that were distributed nationwide across 32 states, including Texas, Florida, Virginia, Kentucky, and California, among others.
The affected product is the M07937 MODULE, OPTIMUS HANDSET 2, with the specified UDI-DI number 00887761984622, manufactured from October 17, 2019 to the present. The source document does not specify what remedy or action affected consumers should take.
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: 9 units Lot/code info: M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.