United StatesMedline 14 Fr Suction Catheter Kits (SKU DYND40972) respiratory convenience kit and Intubation Tray (Adult) containing Suction Catheter Kits (SKU DYNJAA245B) are being recalled; affected kit identifiers include lot 48625040001 (UDI ea 10080196033317, case 40080196033318) and kit lots 25IBC172 and 25HBJ413 (UDI ea 10198459480317, case 40198459480318), distributed nationwide in the U.S. and Canada (141,971 and 130 units). A smaller 8 Fr suction catheter may have been packed instead of the required 14 Fr, which can cause hypoxia and/or respiratory failure from partial or full airway obstruction and may require emergent intervention; other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
What's being recalled
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿ Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distribution US nationwide and Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)