International safety notice
A problem has occurred in Japan where the adhesive part of the circuit comes off and falls off with passive circuit heater wire (adult). I did. The results confirmed that the material had sufficient resistance to strength during clinical use. We have confirmed that several defects have occurred in a specific lot of circuits with heater wire (adult). Since we cannot deny that a defect will occur in this lot, we have decided to recall the lot.
Japan / PMDA Recalls · JPN · Mar 7, 2022
Key facts
| Title | A problem has occurred in Japan where the adhesive part of the circuit comes off and falls off with passive circuit heater wire (adult). I did. The results confirmed that the material had sufficient resistance to strength during clinical use. We have confirmed that several defects have occurred in a specific lot of circuits with heater wire (adult). Since we cannot deny that a defect will occur in this lot, we have decided to recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: General-purpose artificial respirator Sales name: All-in-one VOCSN ventilator |
| Manufacturer | Cafventec Co., Ltd. |
| Models | 018748, PRT-00796-000, 194602 |
| Date | Mar 7, 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