International safety notice

We received a report from a medical institution to which we supply blood leaking from the connection between the needle base and tube when using this product. received. 。 The manufacturer investigated and found that it could not be denied that there was a ripple effect, so they decided to voluntarily recall the affected lot. I did it.

Japan / PMDA Recalls · JPN · Jun 17, 2021

Key facts

Title We received a report from a medical institution to which we supply blood leaking from the connection between the needle base and tube when using this product. received. 。 The manufacturer investigated and found that it could not be denied that there was a ripple effect, so they decided to voluntarily recall the affected lot. I did it.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single use blood collection needle Sales name: Fine Guard SV Blood Collection Set
Manufacturer Top Co., Ltd.
Models 0M21B, 23G×19mm, 0M20B
Date Jun 17, 2021
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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