International safety notice

At an overseas manufacturer, a leak occurred in some lots of three-way stopcocks from the supplier of the three-way stopcocks that are a component of the product. I received a report that. As a result, we will carry out a voluntary recall of the affected lots.

Japan / PMDA Recalls · JPN · Jul 11, 2022

Key facts

Title At an overseas manufacturer, a leak occurred in some lots of three-way stopcocks from the supplier of the three-way stopcocks that are a component of the product. I received a report that. As a result, we will carry out a voluntary recall of the affected lots.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Catheter introducer with hemostasis valve Sales name: Arrow Polyurethane Sheath Introducer Set
Manufacturer Teleflex Medical Japan Co., Ltd.
Models MTO-9903-KU, 71F22A0618
Date Jul 11, 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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