International safety notice

At a medical institution in Japan, the length of the pump tube attached to the cassette part in a semicircle was short, resulting in problems with the combined equipment. It is difficult to attach it to a certain component blood collection device "Haemonetics Component Collection System (CCS)" A complaint has been reported. It turned out that it was attached to the cassette part with a length of We have identified the affected products and decided to voluntarily recall the affected lots of products (40 units).

Japan / PMDA Recalls · JPN · Dec 19, 2022

Key facts

Title At a medical institution in Japan, the length of the pump tube attached to the cassette part in a semicircle was short, resulting in problems with the combined equipment. It is difficult to attach it to a certain component blood collection device "Haemonetics Component Collection System (CCS)" A complaint has been reported. It turned out that it was attached to the cassette part with a length of We have identified the affected products and decided to voluntarily recall the affected lots of products (40 units).
Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Blood circuit for telecentric blood component separation device Sales name: Haemonetics Component Collection Set
Manufacturer Haemonetics Japan LLC
Models 0422034
Date Dec 19, 2022
Regulator page info.pmda.go.jp

At a glance

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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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