International safety notice
We are conducting a voluntary recall because an overseas manufacturer has reported a possible problem with sterilization. A packaging issue was detected during test method validation at the manufacturer.
Japan / PMDA Recalls · JPN · Mar 27, 2024
Key facts
| Title | We are conducting a voluntary recall because an overseas manufacturer has reported a possible problem with sterilization. A packaging issue was detected during test method validation at the manufacturer. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Urinary tract use カテーテル Brand name: Ureteral Access Sheath Retrace/Dilator |
| Manufacturer | Coloplast Co., Ltd. |
| Models | RBD014, 8864944, 8174950, 6928493, 9360599, 7187751, 7362229, 8946228, 8519426, 8619976, 8700201, 8122897 and 6 more |
| Date | Mar 27, 2024 |
| 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