International safety notice
Regarding the product, the general name should be changed to controlled medical device "intestinal tube" and manufacturing and sales certification should be obtained. We are conducting a voluntary recall of this product as it was discovered that the product had been registered for manufacture and sale under the generic name "Colon Perfusion Device."
Japan / PMDA Recalls · JPN · Nov 5, 2021
Key facts
| Title | Regarding the product, the general name should be changed to controlled medical device "intestinal tube" and manufacturing and sales certification should be obtained. We are conducting a voluntary recall of this product as it was discovered that the product had been registered for manufacture and sale under the generic name "Colon Perfusion Device." |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Large intestine perfusion device Sales name: Harman Specular Set |
| Manufacturer | Muranaka Medical Equipment Co., Ltd. |
| Models | 21371611, 21191710, 21221711, 21371810, 21362010, 21171917, 21211511, 21171910, 21271213, 23031913, 21021917, 030-109-33 and 59 more |
| Date | Nov 5, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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