International safety notice
We were informed by the market that there was an error in the labeling of the secondary packaging box. As a result of investigating the records, it was found that the sterilization date and expiration date on the box label of the secondary packaging were incorrectly written only for the target lot products. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jul 21, 2022
Key facts
| Title | We were informed by the market that there was an error in the labeling of the secondary packaging box. As a result of investigating the records, it was found that the sterilization date and expiration date on the box label of the secondary packaging were incorrectly written only for the target lot products. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Short-term use urinary Foley catheter Brand name: Silicone Foley catheter |
| Manufacturer | Fuji Systems Co., Ltd. |
| Models | 0210108, 2204210 |
| Date | Jul 21, 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