International safety notice
The manufacturer of the connector has received a report that leakage occurs from the lock adapter part of the product connector in a specific lot. I received it from the manufacturer. As a result of an investigation by the connector manufacturer, a defect was confirmed in a part of the mold during the molding process at an overseas factory, resulting in damage to the connector. We have decided to take voluntary recall measures as it has become clear that the product may contain some damage.
Japan / PMDA Recalls · JPN · Jun 28, 2022
Key facts
| Title | The manufacturer of the connector has received a report that leakage occurs from the lock adapter part of the product connector in a specific lot. I received it from the manufacturer. As a result of an investigation by the connector manufacturer, a defect was confirmed in a part of the mold during the molding process at an overseas factory, resulting in damage to the connector. We have decided to take voluntary recall measures as it has become clear that the product may contain some damage. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Gravity-type/pump-connection infusion set Brand name: BD Q site closed infusion system |
| Manufacturer | Atom Medical Co., Ltd. |
| Models | 2202102C, 2203032C, 2112082C, 385590-ZAT, 2204042C |
| Date | Jun 28, 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