International safety notice
We have received information from a customer that the sterile packaging of the product in question was found to be unsealed. When we investigated the actual product, we found that an error had occurred in the sterilization packaging sealing process and was overlooked during the inspection. It turned out that it had been leaked. We have decided to carry out a voluntary recall for Lot.
Japan / PMDA Recalls · JPN · Feb 24, 2022
Key facts
| Title | We have received information from a customer that the sterile packaging of the product in question was found to be unsealed. When we investigated the actual product, we found that an error had occurred in the sterilization packaging sealing process and was overlooked during the inspection. It turned out that it had been leaked. We have decided to carry out a voluntary recall for Lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Infusion accessory set Sales name: Closed C |
| Manufacturer | Fortegrow Medical Co., Ltd. |
| Models | 1880-FCC, 211102 |
| Date | Feb 24, 2022 |
| 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