International safety notice
At an overseas manufacturer, we have confirmed that a joint in the main body housing has come loose, causing a leak. As a result, we cannot deny the possibility that a similar defect may occur in a specific manufacturing lot sold in Japan, so we will We will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Nov 21, 2022
Key facts
| Title | At an overseas manufacturer, we have confirmed that a joint in the main body housing has come loose, causing a leak. As a result, we cannot deny the possibility that a similar defect may occur in a specific manufacturing lot sold in Japan, so we will We will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Breathing circuit sterilization filter Brand name: Gibeck Bacteria Filter |
| Manufacturer | Teleflex Medical Japan Co., Ltd. |
| Models | G19212, KMZ20J0601 |
| Date | Nov 21, 2022 |
| 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