International safety notice
We have been informed by the market that the product is packaged with a different type of content compared to the M type label. As a result of the investigation, it was found that the drain tubes themselves were swapped and packaged between the F type and M type. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Sep 7, 2023
Key facts
| Title | We have been informed by the market that the product is packaged with a different type of content compared to the M type label. As a result of the investigation, it was found that the drain tubes themselves were swapped and packaged between the F type and M type. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Sterile indwelling drainage tubes and catheters Sales name: Penrose Drain AR |
| Manufacturer | Fuji Systems Co., Ltd. |
| Models | 2303102, 2303101, 0121240, 0121340, No.40 |
| Date | Sep 7, 2023 |
| 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