International safety notice

Our product “Catheter/Connector for Tube Exchange/Intubation” (product number C-CAE-14.0-70-FI) is It consists of a sensor and two Rapi-Fit connectors. Since a stylet was included in the package, we decided to initiate a voluntary recall. Complaints have been reported, but no health hazards have occurred prior to patient use.

Japan / PMDA Recalls · JPN · Jul 20, 2021

Key facts

Title Our product “Catheter/Connector for Tube Exchange/Intubation” (product number C-CAE-14.0-70-FI) is It consists of a sensor and two Rapi-Fit connectors. Since a stylet was included in the package, we decided to initiate a voluntary recall. Complaints have been reported, but no health hazards have occurred prior to patient use.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single-use breathing circuit connector Brand name: Endotracheal tube replacement/intubation catheter/connector
Manufacturer Cook Medical Japan LLC
Models E4079689
Date Jul 20, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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