International safety notice
Regarding the relevant kit products, Japan has reported that the marker position of the component catheter is written in a position that is different from the specified position. We received a report from a domestic medical institution. It was confirmed that the files were included and mixed. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 17, 2022
Key facts
| Title | Regarding the relevant kit products, Japan has reported that the marker position of the component catheter is written in a position that is different from the specified position. We received a report from a domestic medical institution. It was confirmed that the files were included and mixed. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Spinal subarachnoid and epidural anesthesia kit Sales name: Perifix |
| Manufacturer | B.Brown Ace Scrap Co., Ltd. |
| Models | 21L27H81YD, 21L27H81YE, 21L14H82YC, 21M04H81YD, 21L15H82YR, 21M02H81YH, 21L15H82YH, 21L27H81YF, 21L14H82YN, 21L22H81YC, 21M02H81YL, PCK-049N and 93 more |
| Date | May 17, 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