International safety notice
Regarding the CADD pump infusion set that we manufacture and sell, an overseas manufacturer has notified us of the following two defects. Upon receiving the notification, we will voluntarily recall the affected products, taking into account the product's quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I decided to do so. (1) Due to manufacturing variations, the tube is compressed by the clamp part to prevent free flow, resulting in partial blockage. This may result in a situation where This may result in underdosing or even discontinuation of administration even though the fluid is indicated as being normal. There is a possibility. (2) Due to manufacturing variations in the cassette reservoir, the pump may not be properly installed in the cassette. Even if the cassette is installed, the installation status may not be detected correctly and a cassette missing alarm may occur.
Japan / PMDA Recalls · JPN · Apr 3, 2023
Key facts
| Title | Regarding the CADD pump infusion set that we manufacture and sell, an overseas manufacturer has notified us of the following two defects. Upon receiving the notification, we will voluntarily recall the affected products, taking into account the product's quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I decided to do so. (1) Due to manufacturing variations, the tube is compressed by the clamp part to prevent free flow, resulting in partial blockage. This may result in a situation where This may result in underdosing or even discontinuation of administration even though the fluid is indicated as being normal. There is a possibility. (2) Due to manufacturing variations in the cassette reservoir, the pump may not be properly installed in the cassette. Even if the cassette is installed, the installation status may not be detected correctly and a cassette missing alarm may occur. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Infusion set for infusion pump Brand name: Infusion set for CADD pump |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4098660, 4192023, 4230900, 3667045, 4230899, 4128203, 4227750, 3773550, 4309408, 3667067, 4235022, 3780575 and 482 more |
| Date | Apr 3, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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