Class I Recall of Centurion Medical Products Airway Kit containing Sheridan® Endotracheal Tubes
The U.S. Food and Drug Administration (FDA) has announced the Class I recall of Centurion Medical Products Airway Kit containing Sheridan® Endotracheal Tubes manufactured by Teleflex. Teleflex informed Centurion of its recall for select Sheridan® Endotracheal Tubes and Connectors, as Centurion includes the recalled product in their convenience kit. Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient from the breathing circuit, which may result in insufficient oxygenation, decrease in vital signs, or death.
Four deaths and 18 injuries have been reported to Teleflex in association with disconnection. However, Centurion has no reported injuries or complaints.
The use of affected product may cause serious adverse health consequences, including death.
- Airway Kit containing Sheridan® Endotracheal Tubes
- Model numbers: Kit TC7855 and Component TTCONG0
- Distribution Dates: November 28, 2018 to June 5, 2019
- Devices Recalled in the U.S.: 80 kits, and 70 components not in kits
- Date Recall Initiated: June 7, 2019
Centurion issued a customer notification letter on July 3, 2019, to Medline, the parent company and sole customer for this product, to communicate with affected customers, instructing customers to:
- Identify affected product in inventory
- Return affected product
Customers with questions about this recall may contact Centurion Medical Products Corp. at 517-545-1156.
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