International safety notice
One of the components of our company's "Pigtail Catheter" is the Pigtail Catheter 7Fr. There has been a case where a lithelene type) was severed during indwelling. It is prone to lack of strength due to deterioration over time caused by direct sunlight, fluorescent lights, ultraviolet germicidal lamps, etc., and high temperature and humidity. It turns out that there is a possibility that this may be the case. For this reason, all manufacturing products that use the same catheter and may have the same problem. We have decided to voluntarily recall the lot.
Japan / PMDA Recalls · JPN · Feb 20, 2024
Key facts
| Title | One of the components of our company's "Pigtail Catheter" is the Pigtail Catheter 7Fr. There has been a case where a lithelene type) was severed during indwelling. It is prone to lack of strength due to deterioration over time caused by direct sunlight, fluorescent lights, ultraviolet germicidal lamps, etc., and high temperature and humidity. It turns out that there is a possibility that this may be the case. For this reason, all manufacturing products that use the same catheter and may have the same problem. We have decided to voluntarily recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Short-term biliary catheter (JMDN code: 10696022) Brand name: Ultrasound imaging bile drainage set type C |
| Manufacturer | Hakko Co., Ltd. |
| Models | 211225, 22210210, 210926, 230301, 231229, 210306, 231017, 220225, 221103, 4526737221175, 220702, 210508 |
| Date | Feb 20, 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