International safety notice
In collecting post-market safety management information at overseas manufacturers, Dräger Disposable Breathing Circuit II and Dräger Before or during a ventilation operation using the Disposable Breathing Circuit III, attach the adhesive parts of the target breathing circuit. There have been reports of cases where parts (water traps, Y-pieces, hose connectors, etc.) become loose and fall off partially or completely. I got it. This is due to a manufacturing defect (defective adhesion) of the target product. At this time, we have not received any reports of health hazards in Japan or overseas, but the possibility that the affected products were shipped to the market has been ruled out. Since we were unable to do so, we have decided to begin collection.
Japan / PMDA Recalls · JPN · Mar 31, 2023
Key facts
| Title | In collecting post-market safety management information at overseas manufacturers, Dräger Disposable Breathing Circuit II and Dräger Before or during a ventilation operation using the Disposable Breathing Circuit III, attach the adhesive parts of the target breathing circuit. There have been reports of cases where parts (water traps, Y-pieces, hose connectors, etc.) become loose and fall off partially or completely. I got it. This is due to a manufacturing defect (defective adhesion) of the target product. At this time, we have not received any reports of health hazards in Japan or overseas, but the possibility that the affected products were shipped to the market has been ruled out. Since we were unable to do so, we have decided to begin collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Single-use anesthesia breathing circuit, (2) Anesthesia circuit set Brand name: (1) Dräger disposable breathing circuit II (2) Dräger disposable breathing circuit III |
| Manufacturer | Dräger Japan Co., Ltd. |
| Models | MP03373, 6831.1009.11，6135.2602.21，6995.2811.19，6832.0310.19，6995.0212.19，, 7136.3011.11，6248.2104.22，6204.0804.12，7500.1102.12，6521.2306.12，, 7467.2001.11，6359.0705.22, 6537.2911.10，6613.2112.20，6102.0103.22，6773.2107.12，6422.2710.20，, 7237.0402.11，6118.1702.21，6118.1802.21，6384.2105.11，6020.2103.22，, 7497.1102.11, 7045.1011.11，7137.0112.11，7104.2112.11，7330.2912.11，6247.2904.22，, 6479.2006.12，6319.2504.10，7313.2911.11，6432.1509.10，7366.1202.12，, 6135.2602.11，6459.0906.11，6770.0109.11, 6431.0710.20，6434.1510.20，6532.1610.10，7009.0512.20，7030.2310.11，, MP00351 and 30 more |
| Date | Mar 31, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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