International safety notice
A case in which a 7Fr. pigtail catheter (polyethylene type), one of the components of the product, was severed while indwelling. has occurred. It has been found that there is a risk that the material may be susceptible to lack of strength due to deterioration over time caused by high temperature and humidity. Therefore, we have decided to voluntarily recall all production lots that may have similar defects.
Japan / PMDA Recalls · JPN · Feb 20, 2024
Key facts
| Title | A case in which a 7Fr. pigtail catheter (polyethylene type), one of the components of the product, was severed while indwelling. has occurred. It has been found that there is a risk that the material may be susceptible to lack of strength due to deterioration over time caused by high temperature and humidity. Therefore, we have decided to voluntarily recall all production lots that may have similar defects. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Short-term biliary catheter (JMDN code: 10696022) Brand name: Pigtail catheter |
| Manufacturer | Hakko Co., Ltd. |
| Models | 220716, 210609, 220303, 220521, 4526737221199, 210406, 230503, 4526737221205, 210317, 211012, 220203, 210926 and 27 more |
| Date | Feb 20, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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