International safety notice
Carbon plastic snaps (hereinafter referred to as studs) and grommets (hereinafter referred to as abutments) are being manufactured on the production line at 3M Canada's factory. There was a flaw in the adjustment of the process of crimping the eyelet (eyelet), and when force was applied from outside, such as when connecting the lead wire during use, the eyelet It was confirmed that some of the electrodes were broken and the studs were detached from the electrode body. Because there is a risk of
Japan / PMDA Recalls · JPN · Sep 28, 2021
Key facts
| Title | Carbon plastic snaps (hereinafter referred to as studs) and grommets (hereinafter referred to as abutments) are being manufactured on the production line at 3M Canada's factory. There was a flaw in the adjustment of the process of crimping the eyelet (eyelet), and when force was applied from outside, such as when connecting the lead wire during use, the eyelet It was confirmed that some of the electrodes were broken and the studs were detached from the electrode body. Because there is a risk of |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use electrocardiogram electrode Brand name: 3M X-ray transparent monitoring electrode |
| Manufacturer | 3M Japan Innovation Co., Ltd. |
| Models | 202302LL, 202302LM, 202302LK |
| Date | Sep 28, 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