International safety notice
It was discovered that the product in question may have been contaminated with a product whose sterile packaging was damaged. has launched a voluntary recall measure for all lots of products within the sterilization shelf life. has decided to launch similar voluntary recall measures.
Japan / PMDA Recalls · JPN · Apr 10, 2023
Key facts
| Title | It was discovered that the product in question may have been contaminated with a product whose sterile packaging was damaged. has launched a voluntary recall measure for all lots of products within the sterilization shelf life. has decided to launch similar voluntary recall measures. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Extracorporeal membrane artificial lung Brand name: (1) Membrane oxygenator QUADROX-i series (2) Membrane oxygenator QUADROX-i for newborns and children |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 3000222044, 3000207116, 3000193266, 3000228078, 3000233351, 30000, 3000176721, 3000224067, 3000261398, 3000256785, 3000269538, 3000217259 and 54 more |
| Date | Apr 10, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1,000+ Matching device models in FDA data
- 1,000+ Matching catalog numbers in FDA data
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