International safety notice
In some of the products in the lot, when the screw cap was tightened due to poor molding of the outlet port (drainage port). The possibility of cracks occurring in the pipe cannot be completely ruled out, and if cracks occur, there is a risk of poor suction and leakage of waste fluid. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Apr 27, 2021
Key facts
| Title | In some of the products in the lot, when the screw cap was tightened due to poor molding of the outlet port (drainage port). The possibility of cracks occurring in the pipe cannot be completely ruled out, and if cracks occur, there is a risk of poor suction and leakage of waste fluid. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Drain bag Brand name: Medline drainage system reservoir |
| Manufacturer | Medline Japan LLC |
| Models | DYNJWE1200SET, CSI20090002J, CSI20100005J |
| Date | Apr 27, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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