International safety notice
Regarding the Portex stylet that we manufacture and sell, we received a request from a medical institution with the product number: 100/120/200. We received a report that a labeled box contained a product with a different product number: 100/120/300. When we conducted an investigation at an overseas manufacturer, we found that incorrect It was discovered that the size of the product may include part number 100/120/300 (stylet_outer diameter 5.0mm). We have been informed that measures will be taken to ensure the safety of the market. In response to this communication, we have taken appropriate measures, taking into consideration the quality, efficacy and safety of the product, the impact on patients, and compliance with laws and regulations. We have decided to carry out a voluntary recall of elephant products.
Japan / PMDA Recalls · JPN · Aug 17, 2021
Key facts
| Title | Regarding the Portex stylet that we manufacture and sell, we received a request from a medical institution with the product number: 100/120/200. We received a report that a labeled box contained a product with a different product number: 100/120/300. When we conducted an investigation at an overseas manufacturer, we found that incorrect It was discovered that the size of the product may include part number 100/120/300 (stylet_outer diameter 5.0mm). We have been informed that measures will be taken to ensure the safety of the market. In response to this communication, we have taken appropriate measures, taking into consideration the quality, efficacy and safety of the product, the impact on patients, and compliance with laws and regulations. We have decided to carry out a voluntary recall of elephant products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use endotracheal tube stylet Sales name: Portex Stylet |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4015424 |
| Date | Aug 17, 2021 |
| 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