International safety notice

An overseas manufacturer has informed us that the product peels off easily when removed from the liner paper during use, which may cause problems in use. I received it. We have decided to voluntarily recall products with the relevant lot numbers that were shipped to the Japanese market.

Japan / PMDA Recalls · JPN · Oct 19, 2022

Key facts

Title An overseas manufacturer has informed us that the product peels off easily when removed from the liner paper during use, which may cause problems in use. I received it. We have decided to voluntarily recall products with the relevant lot numbers that were shipped to the Japanese market.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single use general purpose surgical drape Sales name: Steri Drape Surgical drape
Manufacturer 3M Japan Innovation Co., Ltd.
Models 33HC74, 33JA5D, 33KE37, 33J4E7, 33JED6, 33JKD4, 33JHYT, 33HXMD, 33HHKC, 33JWDD
Date Oct 19, 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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