International safety notice
In a specification verification test at an overseas manufacturer, the sterilized packaging (individual packaging) of the spare cap included with the product was found to be extremely rare. Due to damage such as "kinks" being observed on the product, which may impair the sterility of the product, We have decided to begin collection.
Japan / PMDA Recalls · JPN · Jun 1, 2021
Key facts
| Title | In a specification verification test at an overseas manufacturer, the sterilized packaging (individual packaging) of the spare cap included with the product was found to be extremely rare. Due to damage such as "kinks" being observed on the product, which may impair the sterility of the product, We have decided to begin collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Blood storage tank for artificial heart and lung (2) Extracorporeal membrane type artificial lung Brand name: (1) VHK venous hard shell reservoir for newborns and children (2) Membrane oxygenator QUADROX-i for newborns and children |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 92275882, 92309785, 92285488, 92288896, 92286236, 92255923, BO-VKMO10000, 92298798, 92292626, 92284145, 92311338, 92308927 and 10 more |
| Date | Jun 1, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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