International safety notice
We received a report from a customer that the needle part came off from the Huber needle after use. As a result, we confirmed a problem in the manufacturing process of Huber needles. We have received a report from the overseas manufacturer stating that we have decided to recall the product as it has become clear that the occurrence of a similar event cannot be ruled out. I did. Ta.
Japan / PMDA Recalls · JPN · Apr 30, 2024
Key facts
| Title | We received a report from a customer that the needle part came off from the Huber needle after use. As a result, we confirmed a problem in the manufacturing process of Huber needles. We have received a report from the overseas manufacturer stating that we have decided to recall the product as it has become clear that the occurrence of a similar event cannot be ruled out. I did. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Implant Port for Extended Use Infusion Sales name: Sofaport |
| Manufacturer | TKB Co., Ltd. |
| Models | 71127, 71155, 71136, 71124, SP10030N, 71154, 71119, 71128, 71139, 71118, 71138, 71137 and 29 more |
| Date | Apr 30, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 10–99 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