International safety notice
A domestic medical institution said that the effective length displayed on the label was different from the specifications. I received the information. The effective length and F size can be inferred from the product number, but the product label states that the effective length is 11cm, It was revealed that the inner diameter was 2.90mm, which was different from the actual description. Therefore, we will voluntarily recall the products with the relevant part numbers and serial numbers.
Japan / PMDA Recalls · JPN · Dec 24, 2021
Key facts
| Title | A domestic medical institution said that the effective length displayed on the label was different from the specifications. I received the information. The effective length and F size can be inferred from the product number, but the product label states that the effective length is 11cm, It was revealed that the inner diameter was 2.90mm, which was different from the actual description. Therefore, we will voluntarily recall the products with the relevant part numbers and serial numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Cardiac Catheter Introducer Kit Sales name: Zemex Introducer Set |
| Manufacturer | Zeon Medical Co., Ltd. |
| Models | ISA1650BBLS, 211112T1, ISA1190ABQS, ISA1630006S, ISA2550BBJS, 211116T1, 211104T1, ISA1640BBJS, ISA2550AAAS, 211025T1, 211020T1, 211108T1 and 6 more |
| Date | Dec 24, 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