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Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
Smiths Medical is recalling specific lots of the BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which can lead to inadequate ventilation and increased risk of aspiration.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Smiths Medical customer service at 1-(800)-0258-5361 or Customerservice@icumed.com.
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