International safety notice

When we investigated in-house inventory based on defect information provided by customers, we found that there was a label on the front and back of the product's individual packaging (one side had an "optional" label on it). It was discovered that the contents of the product lot labeled "Mote (female side)" were sealed in a manner contrary to what was indicated. We have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Jun 28, 2021

Key facts

Title When we investigated in-house inventory based on defect information provided by customers, we found that there was a label on the front and back of the product's individual packaging (one side had an "optional" label on it). It was discovered that the contents of the product lot labeled "Mote (female side)" were sealed in a manner contrary to what was indicated. We have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: male contraceptive condom Brand name: Fuji Condom
Manufacturer Fuji Latex Co., Ltd.
Models 1E20EWF1
Date Jun 28, 2021
Regulator page info.pmda.go.jp

At a glance

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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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