International safety notice
The product in question was not properly sterilized with ethylene oxide gas, and sterility was not guaranteed. A notice from the manufacturer revealed this possibility. We will voluntarily recall the product in accordance with the manufacturer's instructions.
Japan / PMDA Recalls · JPN · May 28, 2021
Key facts
| Title | The product in question was not properly sterilized with ethylene oxide gas, and sterility was not guaranteed. A notice from the manufacturer revealed this possibility. We will voluntarily recall the product in accordance with the manufacturer's instructions. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: pneumoperitoneum tube Brand name: Pneumoperitoneum tubing set |
| Manufacturer | MC Medical Co., Ltd. |
| Models | K03112201, 19C0145FAX, 18L0473FAX, K03112225, 19J0567FAX, 19D0638FAX, 18L0474FAX, 19E0682FAX, 18L1286FAX, 19K0524FAX, 19K1052FAX, 19E0681FAX |
| Date | May 28, 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