International safety notice
We received a report from a medical institution regarding a hose crack caused by the product, and after conducting an investigation, we found that Regarding the product, it was found that the hose rim support part was not formed sufficiently, which caused it to be unable to withstand external loads and cracked. This is due to manufacturing defects in some lot products. We have decided to carry out a voluntary recall of the affected lots.
Japan / PMDA Recalls · JPN · Mar 12, 2024
Key facts
| Title | We received a report from a medical institution regarding a hose crack caused by the product, and after conducting an investigation, we found that Regarding the product, it was found that the hose rim support part was not formed sufficiently, which caused it to be unable to withstand external loads and cracked. This is due to manufacturing defects in some lot products. We have decided to carry out a voluntary recall of the affected lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Air Pad Specific Warming Device System Sales name: Karima hot air heating system (*) |
| Manufacturer | Inspired Medical Japan Co., Ltd. |
| Models | 232701, 221202462, 230700010, 230700006, 221202465, 230700054, 220801355, 230700038, 221202133, 230700005, 230700064, 230400019 and 151 more |
| Date | Mar 12, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 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