International safety notice
As a result of an investigation at an overseas manufacturer, the residual endotoxin level in some of the raw materials of the target product slightly exceeded the standard value. It has become clear that the possibility cannot be ruled out. We have decided to voluntarily recall the items.
Japan / PMDA Recalls · JPN · Oct 11, 2024
Key facts
| Title | As a result of an investigation at an overseas manufacturer, the residual endotoxin level in some of the raw materials of the target product slightly exceeded the standard value. It has become clear that the possibility cannot be ruled out. We have decided to voluntarily recall the items. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Sponge with X-ray contrast agent Sales name: CODMAN Surgical Patty |
| Manufacturer | Integra Japan Co., Ltd. |
| Models | 5311207, 6647384, J93K54, 7281686, 7062033, 7333068, 7281819, J7494N, 5775813, 7122091, 7005533, J9464U and 239 more |
| Date | Oct 11, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models 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