International safety notice
A medical institution we supply to has informed us that during an inspection of the pump, it was confirmed that the flow of the drug solution was not completely stopped when the infusion was stopped. I received a report. When using flow infusion set NP), depending on the position of the finger when the pump is stopped, the tube may not be completely removed. It was confirmed that the product could not be crushed completely and a slight flow of the chemical solution occurred. This phenomenon will not occur. Therefore, we are conducting a voluntary recall of products with the relevant serial numbers to improve the strength of holding down the tube. That's it.
Japan / PMDA Recalls · JPN · Nov 12, 2021
Key facts
| Title | A medical institution we supply to has informed us that during an inspection of the pump, it was confirmed that the flow of the drug solution was not completely stopped when the infusion was stopped. I received a report. When using flow infusion set NP), depending on the position of the finger when the pump is stopped, the tube may not be completely removed. It was confirmed that the product could not be crushed completely and a slight flow of the chemical solution occurred. This phenomenon will not occur. Therefore, we are conducting a voluntary recall of products with the relevant serial numbers to improve the strength of holding down the tube. That's it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose infusion pump Brand name: Top infusion pump TOP-2500 |
| Manufacturer | Top Co., Ltd. |
| Models | 12522, RR00646, RQ00186, RQ00110, RQ00176, 12523, RR01121, TOP-2500, RR01104, RR00642, 00781, RQ00270 and 25 more |
| Date | Nov 12, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 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