International safety notice
Although the header and housing of this product are ultrasonically welded, there have been multiple reports of liquid leakage from this location in some products. There were several. Due to the risk of liquid leakage from the affected area, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Aug 25, 2021
Key facts
| Title | Although the header and housing of this product are ultrasonically welded, there have been multiple reports of liquid leakage from this location in some products. There were several. Due to the risk of liquid leakage from the affected area, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Hemodialysis filter Brand name: Polyflux H Hemodia Filter |
| Manufacturer | Baxter Corporation |
| Models | 0-5502-H-05, 0-5502-H-04, 0-5502-H-03, 0-5502-H-06, 0-5502-H-02, 0-5502-H-01, 955608 |
| Date | Aug 25, 2021 |
| 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