International safety notice
Regarding the anesthesia infusion set that we manufacture and sell, we have been contacted by an overseas manufacturer regarding the following two defects. voluntarily recall the affected products, taking into account the product's quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I'm here. (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 anesthesia infusion set that we manufacture and sell, we have been contacted by an overseas manufacturer regarding the following two defects. voluntarily recall the affected products, taking into account the product's quality, efficacy, safety, impact on patients, and compliance with laws and regulations. I'm here. (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: Anesthesia infusion set Brand name: CADD anesthesia infusion set |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 4256989, 4207870, 4222388, 4168766, 4146563, 4189938, 21-7609-24, 4196390, 4271157, 21-7624-24, 4302529, 4185823 and 51 more |
| Date | Apr 3, 2023 |
| 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