International safety notice
The approval details for adding Terfusion infusion set (DEHP-free), which is a kit component, to the kit are as follows: Purchase products that have been sterilized by EOG or γ-ray sterilization from the supplier and use them as components of the kit, but do not use electron beam sterilization. As it was discovered that the product was purchased and used as a component of a kit, the kit containing the component was voluntarily recalled. I decided to do it.
Japan / PMDA Recalls · JPN · Aug 3, 2023
Key facts
| Title | The approval details for adding Terfusion infusion set (DEHP-free), which is a kit component, to the kit are as follows: Purchase products that have been sterilized by EOG or γ-ray sterilization from the supplier and use them as components of the kit, but do not use electron beam sterilization. As it was discovered that the product was purchased and used as a component of a kit, the kit containing the component was voluntarily recalled. I decided to do it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class IV Treatment Kit Sales name: (1) General surgery kit (2) Brain surgery kit (3) Urology kit (4) Orthopedic surgery kit |
| Manufacturer | Hogy Medical Co., Ltd. |
| Models | 2Z32120956, 32321209FW, 36321206Y2, 660837Z98116, 353212065X, 353212051R, 36321208L3, 33321208X8, 34321205WR, 35321205XR, 33321202J9, 2Z321207WS and 42 more |
| Date | Aug 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