Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Reason for recall: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. Distribution: US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey Quantity: 2523 units Lot/code info: No UDI/Lots: 240620 240610 240418 240326 230612 WO07066 WO07010 WO06020 WO05019 WO04884 WO04827 WO04756 WO04714 WO04656 WO04625 WO04596 WO04553 WO04398 WO04356 WO04061 WO03846 WO03748 WO03688
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.