International safety notice

We have been informed by an overseas manufacturer that some products may have been shipped with damaged sterile packaging. If the packaging is damaged, we cannot guarantee the sterilization of the product, so we will not be able to replace the product that has already been shipped. Therefore, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Aug 16, 2023

Key facts

Title We have been informed by an overseas manufacturer that some products may have been shipped with damaged sterile packaging. If the packaging is damaged, we cannot guarantee the sterilization of the product, so we will not be able to replace the product that has already been shipped. Therefore, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common Name: Single Use Trocar Sleeve Sales name: Hybrid single-use strocker
Manufacturer B.Brown Ace Scrap Co., Ltd.
Models 52622854, 52683477, 52554510, 52460844, 52528335, 52461173, 52779522, 52758747, 52791500, 52743751, 52511804, 52520819 and 143 more
Date Aug 16, 2023
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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