Medline 14 Fr Suction Catheter Kits recalled for wrong catheter size
What this means
Some Medline 14 Fr Suction Catheter Kits (SKU DYND40972) may contain a smaller 8 Fr catheter instead of the correct 14 Fr size. Using the wrong size catheter can partially or completely block the airway, leading to low oxygen levels and breathing failure that may require emergency treatment.
- Check your kit SKU DYND40972 for lot number 48625040001
- Do not use the kit if you have the affected lot number
- Contact your supplier or Medline for a replacement
- If a patient shows signs of airway obstruction or low oxygen after using this kit, seek emergency medical care immediately
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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