International safety notice

Component medical device "Connector three-way stopcock" incorporated in the kit product (Manufacturer: Nippon Becton Dickinson Co., Ltd.) The manufacturer has notified us that they will be conducting a voluntary recall due to the risk of leakage from the lock adapter part. there was. In response to this, our company will also carry out a voluntary recall of the target products that incorporate the component medical devices. Did.

Japan / PMDA Recalls · JPN · Jun 28, 2022

Key facts

Title Component medical device "Connector three-way stopcock" incorporated in the kit product (Manufacturer: Nippon Becton Dickinson Co., Ltd.) The manufacturer has notified us that they will be conducting a voluntary recall due to the risk of leakage from the lock adapter part. there was. In response to this, our company will also carry out a voluntary recall of the target products that incorporate the component medical devices. Did.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Cardiac catheter introducer kit Brand name: Medikit Catheter Introducer Kit
Manufacturer Togo Medikit Co., Ltd.
Models CK3968, 22F0907, CK4195, 22F1304, CK4155, CKP575011MS-AR2500C, CK3181, CKN10, CK2191, CKN546017MS-AR250AC, CKI44, CK4551 and 30 more
Date Jun 28, 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

Browse all International device safety notices