International safety notice

A medical institution in Japan told me that the female connector and male connector of this product cannot be locked when connected (male connector As a result of our investigation, we found that the pressure of the spring, which is an internal component of the female connector, was There are variations in length when compressed, and some products may be shipped that cannot be locked when connected to a male connector. I decided. We have decided to carry out a voluntary recall as some of the shipped products may contain products in a similar condition. I did.

Japan / PMDA Recalls · JPN · Jul 4, 2022

Key facts

Title A medical institution in Japan told me that the female connector and male connector of this product cannot be locked when connected (male connector As a result of our investigation, we found that the pressure of the spring, which is an internal component of the female connector, was There are variations in length when compressed, and some products may be shipped that cannot be locked when connected to a male connector. I decided. We have decided to carry out a voluntary recall as some of the shipped products may contain products in a similar condition. I did.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Closed drug transfer system Brand name: Chemosafelock
Manufacturer Terumo Corporation
Models 5851020, KL-BS001U3
Date Jul 4, 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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