A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Reason for recall: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea. Distribution: Distribution US nationwide and Canada. Quantity: 141,971 Lot/code info: Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
48625040001, 10080196033317, 40080196033318
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.