International safety notice
Dräger Disposable Breathing Circuits and Dräger Disposable Breathing Circuits and We have received information that foreign matter has been found in the disposable breathing circuit III. The cause of foreign matter contamination is a manufacturing defect in the target product, and components used in the circuit material remain in the circuit as particles. It was something that existed. In our investigation, we determined that it would be difficult to detect these particles during a visual inspection of the product before use. At this time, we have not received any reports of being affected by these particles in Japan or overseas. As we could not rule out the possibility that the product had been shipped to the market, we decided to begin a recall. Regarding applicable products, all lots shipped in the past are eligible, but the expiration date of applicable products is 3 years, so This applies to all lots shipped after 2020.
Japan / PMDA Recalls · JPN · Mar 16, 2023
Key facts
| Title | Dräger Disposable Breathing Circuits and Dräger Disposable Breathing Circuits and We have received information that foreign matter has been found in the disposable breathing circuit III. The cause of foreign matter contamination is a manufacturing defect in the target product, and components used in the circuit material remain in the circuit as particles. It was something that existed. In our investigation, we determined that it would be difficult to detect these particles during a visual inspection of the product before use. At this time, we have not received any reports of being affected by these particles in Japan or overseas. As we could not rule out the possibility that the product had been shipped to the market, we decided to begin a recall. Regarding applicable products, all lots shipped in the past are eligible, but the expiration date of applicable products is 3 years, so This applies to all lots shipped after 2020. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) anesthesia circuit set, (2) single-use anesthesia breathing circuit Brand name: (1) Dräger disposable breathing circuit III (2) Dräger disposable breathing circuit |
| Manufacturer | Dräger Japan Co., Ltd. |
| Models | 200720, MP00305, 200413, 200323, 221212, 210405, 201130, 220110, 210809, 200316, 210308, 200817 and 37 more |
| Date | Mar 16, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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