International safety notice

The lot was manufactured and shipped at a manufacturing facility (storage of final products) that was not registered in the manufacturing and sales certificate. and shipped to the customer. Due to this, we will recall the lot.

Japan / PMDA Recalls · JPN · Aug 3, 2022

Key facts

Title The lot was manufactured and shipped at a manufacturing facility (storage of final products) that was not registered in the manufacturing and sales certificate. and shipped to the customer. Due to this, we will recall the lot.
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Suction-type tissue production needle キット Brand name: Bird Bacola Biopsy System
Manufacturer Medicon Co., Ltd.
Models VC10118MRS, HUEX1803
Date Aug 3, 2022
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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