International safety notice
In some production lots of this product, products failed the quality inspection conducted at the overseas manufacturer during the assembly process. It turns out that it was shipped to the market by mistake. Ta.
Japan / PMDA Recalls · JPN · Sep 22, 2022
Key facts
| Title | In some production lots of this product, products failed the quality inspection conducted at the overseas manufacturer during the assembly process. It turns out that it was shipped to the market by mistake. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pericardial prosthesis Sales name: Gore Cardio Foam ASD Occluder |
| Manufacturer | Japan Gore LLC |
| Models | 24470165, 24470146, 24399987, 24399986, ASD44J, 24399984, 24470145, 24399985, 24470144, ASD37J, 24470143, 24399988 and 2 more |
| Date | Sep 22, 2022 |
| 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