International safety notice
During the manufacturing process, damage (pinholes) were found in specific locations in the sterile packaging of some products. Voluntary recall of products manufactured at the same time on the line whose sterile packaging may have been damaged. That's what I said.
Japan / PMDA Recalls · JPN · Jul 5, 2024
Key facts
| Title | During the manufacturing process, damage (pinholes) were found in specific locations in the sterile packaging of some products. Voluntary recall of products manufactured at the same time on the line whose sterile packaging may have been damaged. That's what I said. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Enteral feeding infusion set for pumps Brand name: (1) Fresenius pump enteral feeding set (2) Enteral feeding set for Fresenius Amika pump |
| Manufacturer | Fresenius Kabi Japan Co., Ltd. |
| Models | 240405.68, 240321.68, 240326.68, 240323.68, 240410.68, 240409.68, 240322.68, 240406.68, JF-3YP30Q, 240320.68, JF-3YP30AQ, 240407.68 and 5 more |
| Date | Jul 5, 2024 |
| 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