Device product
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Z-1313-2026
Product summary
- Event
- Event 98285
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 130
- Official record key
device-enforcement:Z-1313-2026
Official wording
Reason: 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.
Code information: Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Unknown
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.