International safety notice

In this lot, it was confirmed that leaks occurred due to loose connections depending on the installation method, and We decided to voluntarily recall the product because we could not deny the possibility that an accident might occur.

Japan / PMDA Recalls · JPN · Dec 8, 2023

Key facts

Title In this lot, it was confirmed that leaks occurred due to loose connections depending on the installation method, and We decided to voluntarily recall the product because we could not deny the possibility that an accident might occur.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Anesthesia circuit set Sales name: T-FLEX Anesthesia/Respiration circuit set
Manufacturer Total Medical Supply Co., Ltd.
Models TF-0122, 20230628046
Date Dec 8, 2023
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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