International safety notice

Due to a defect found in one of the parts that make up this product during the heat treatment process, it will gradually become worse after repeated use. We have decided to voluntarily recall the product because it was discovered that the stopper may be deformed and may not be able to be released.

Japan / PMDA Recalls · JPN · Mar 20, 2023

Key facts

Title Due to a defect found in one of the parts that make up this product during the heat treatment process, it will gradually become worse after repeated use. We have decided to voluntarily recall the product because it was discovered that the stopper may be deformed and may not be able to be released.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Creator Sales name: Spreader
Manufacturer Tanaka Medical Instruments Manufacturing Co., Ltd.
Models 21AA02
Date Mar 20, 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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