International safety notice
When we inspected this product at a medical facility, we received a report that it was unable to supply oxygen. This is a product where the opening of the "oxygen tube connection port" in the intake valve cap was blocked due to a manufacturing defect. As a result of this discovery, we have decided to carry out a voluntary recall of affected products that have already been shipped.
Japan / PMDA Recalls · JPN · Jun 14, 2022
Key facts
| Title | When we inspected this product at a medical facility, we received a report that it was unable to supply oxygen. This is a product where the opening of the "oxygen tube connection port" in the intake valve cap was blocked due to a manufacturing defect. As a result of this discovery, we have decided to carry out a voluntary recall of affected products that have already been shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reusable manual pulmonary resuscitator Sales name: Silicon Resashi Bag |
| Manufacturer | Nakamura Medical Industry Co., Ltd. |
| Models | 210927, NK-101MR, 0155990, 0155594, 211013, 0155893, 0156073, 0155546, 0155571, 0156057, 0156062, NK-102MR |
| Date | Jun 14, 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