International safety notice

Because it is not possible to confirm the shipping judgment record of this product, and the quality and safety cannot be guaranteed. We have decided to recall all shipped products.

Japan / PMDA Recalls · JPN · Apr 8, 2024

Key facts

Title Because it is not possible to confirm the shipping judgment record of this product, and the quality and safety cannot be guaranteed. We have decided to recall all shipped products.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Angioplasty balloon pressurizer Sales name: SELEPUMP
Manufacturer Date Medical Service Co., Ltd.
Models K-P-30S, K-P-40IS, P2305192001, P2305193001
Date Apr 8, 2024
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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