International safety notice
We manufacture and sell PORTEX/Nasal Airway, Catheter Mount, PORTEX/Thermovent. In the bacterial package, it is specified that some products may not be able to guarantee the integrity of some seals. We have been informed that a voluntary recall will be conducted regarding the product and lot. In consideration of quality effectiveness, the impact on patients, and compliance with laws and regulations, we decided to voluntarily collect the target products.
Japan / PMDA Recalls · JPN · Jan 21, 2025
Key facts
| Title | We manufacture and sell PORTEX/Nasal Airway, Catheter Mount, PORTEX/Thermovent. In the bacterial package, it is specified that some products may not be able to guarantee the integrity of some seals. We have been informed that a voluntary recall will be conducted regarding the product and lot. In consideration of quality effectiveness, the impact on patients, and compliance with laws and regulations, we decided to voluntarily collect the target products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: Nasopharyngeal head for short-term use, nasopharyngeal head for single use, nasopharyngeal head for single use, artificial nose Brand name: (1) Portex Nasal Airway (2) Catheter mount (3) PORTEX/Thermovent |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4089150, 4107296, 4110350, 4133226, 4122012，, 4119729, 4104267, 4133228, 4107295, 4133814, 4109287, 4159808 and 33 more |
| Date | Jan 21, 2025 |
| 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