International safety notice
We received a call from a medical institution that the pump door was wobbling when opening and closing, and as a result of our investigation, we found that the pin press-fitted into the door hinge body. It was discovered that there were some cases where the retention strength of the bolts did not meet the design specifications. Therefore, after checking the door hinges at two locations on the products subject to recall, we will check for products whose pin retention force does not meet the design specifications. decided to carry out a voluntary recall to replace the door hinges with ones that meet the design strength.
Japan / PMDA Recalls · JPN · Jul 26, 2021
Key facts
| Title | We received a call from a medical institution that the pump door was wobbling when opening and closing, and as a result of our investigation, we found that the pin press-fitted into the door hinge body. It was discovered that there were some cases where the retention strength of the bolts did not meet the design specifications. Therefore, after checking the door hinges at two locations on the products subject to recall, we will check for products whose pin retention force does not meet the design specifications. decided to carry out a voluntary recall to replace the door hinges with ones that meet the design strength. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose infusion pump Brand name: CureSense infusion pump IP-100 |
| Manufacturer | Metek Co., Ltd. |
| Models | 20K0126D1, 21A0673D, 20K0082D1, 20K0152D, 20L0457D, 20K0001DS1, 90203, 20K0076D1, 20J0015D1, 20L0295D, 90192, 21A0551D and 74 more |
| Date | Jul 26, 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