International safety notice
The product was voluntarily recalled on December 11, 2019 due to a defect in the sterilization packaging, but the product will no longer be manufactured. Originally, we received complaints regarding multiple defects in sterile packaging for products from the above-mentioned voluntary recall lots. We have received notification that a voluntary recall will be implemented for the relevant lot. After checking our shipping records, we confirmed that the relevant lot of the subject product had been shipped to the market. We have decided to implement a recall.
Japan / PMDA Recalls · JPN · Oct 7, 2021
Key facts
| Title | The product was voluntarily recalled on December 11, 2019 due to a defect in the sterilization packaging, but the product will no longer be manufactured. Originally, we received complaints regarding multiple defects in sterile packaging for products from the above-mentioned voluntary recall lots. We have received notification that a voluntary recall will be implemented for the relevant lot. After checking our shipping records, we confirmed that the relevant lot of the subject product had been shipped to the market. We have decided to implement a recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use electrode cleaner Brand name: Tip cleaner |
| Manufacturer | Japan Medical Next Co., Ltd. |
| Models | 18SEP12, 18DEC05, 19MAR14, 18OCT03, 19FEB13, 18JUL27A, 19JAN30, 19MAR29, 18NOV21A, 19JAN16, 18NOV21, 18APR09 and 5 more |
| Date | Oct 7, 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