International safety notice
1 lot of Ospica Heart Wire (Model: TME67ZC) from a domestic trading facility. (P353393-12), we received a report that a product (model number: TME66TC-5) that differs from the outer box display was mixed in. As a result of an investigation into the cause by Ospica, the manufacturer, in the manufacturing process, It was discovered that a different product was accidentally mixed into some of the products in the lot. Based on instructions from the manufacturer, we have decided to voluntarily recall the products in question.
Japan / PMDA Recalls · JPN · Feb 21, 2024
Key facts
| Title | 1 lot of Ospica Heart Wire (Model: TME67ZC) from a domestic trading facility. (P353393-12), we received a report that a product (model number: TME66TC-5) that differs from the outer box display was mixed in. As a result of an investigation into the cause by Ospica, the manufacturer, in the manufacturing process, It was discovered that a different product was accidentally mixed into some of the products in the lot. Based on instructions from the manufacturer, we have decided to voluntarily recall the products in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac electrode for external pacemaker Sales name: Ospica Heart Wire |
| Manufacturer | Heiwa Bussan Co., Ltd. |
| Models | TME67ZC, P353393-12 |
| Date | Feb 21, 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