International safety notice
As a result of an investigation of overseas manufacturers, the sealing of the sterile packaging (the outer sterile packaging for double-wrapped products) may not be perfect. It has become clear that. Therefore, it may contain products that cannot guarantee asepticism, so that the product is voluntarily collected. I did it.
Japan / PMDA Recalls · JPN · Jan 21, 2025
Key facts
| Title | As a result of an investigation of overseas manufacturers, the sealing of the sterile packaging (the outer sterile packaging for double-wrapped products) may not be perfect. It has become clear that. Therefore, it may contain products that cannot guarantee asepticism, so that the product is voluntarily collected. I did it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: (1) (2) (3) Short -term urology Forley Cathetell (4) Short -term use of pubic Urgi urology (5) Short -term use bile duct catheter Sales name: (1) Poljes Foricyl Catheter III (2) Porges Xflow catheter (3) Catheter for Polger urology (4) Catheter for Polger urology (5) Polge gastrointestinal catheter |
| Manufacturer | Coloplast Co., Ltd. |
| Models | 84315, 7735546, 7585017, 8691247, 8157025, 8442223, 7835619, 8244814, 7516983, 8620012, 8979456, 8009485 and 1414 more |
| Date | Jan 21, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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