International safety notice
We have received a report from a medical institution to which we supply the product that a chemical solution leaks from the PCA device when using this product. When we investigated the cause of this, we found a crack in one of the internal components of the PCA device that connects the chemical flow path with the outside. It was confirmed that this was caused by chemical leakage. Since this event may occur in a specific molded lot of component parts, we have determined that there is a ripple effect and We have decided to carry out a voluntary recall of products using this product.
Japan / PMDA Recalls · JPN · Jun 8, 2021
Key facts
| Title | We have received a report from a medical institution to which we supply the product that a chemical solution leaks from the PCA device when using this product. When we investigated the cause of this, we found a crack in one of the internal components of the PCA device that connects the chemical flow path with the outside. It was confirmed that this was caused by chemical leakage. Since this event may occur in a specific molded lot of component parts, we have determined that there is a ripple effect and We have decided to carry out a voluntary recall of products using this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pressurized pharmaceutical syringe Sales name: Syringector I |
| Manufacturer | Daiken Medical Co., Ltd. |
| Models | A210203X, A210204X, A210126D, A210209D, A210204D, ISJ6-E10-IP1-E1006, ISJ6-E0510-IP1-E1006, A210203D, A210126X |
| Date | Jun 8, 2021 |
| 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