International safety notice
Some lots (Lot P3) of "Ospica external pacemaker relay cable (model number: D2P-SP)" were received from a domestic trading facility. 42142-08), we have received a report that a product (model number: D2-SP) was enclosed that differs from the labeling on the outer box and sterilization bag. Ta. As a result of an investigation by Ospica, the overseas manufacturer, it was discovered that a different product had been mistakenly inserted during the manufacturing process. Therefore, we have decided to voluntarily recall the products from this lot.
Japan / PMDA Recalls · JPN · Apr 14, 2022
Key facts
| Title | Some lots (Lot P3) of "Ospica external pacemaker relay cable (model number: D2P-SP)" were received from a domestic trading facility. 42142-08), we have received a report that a product (model number: D2-SP) was enclosed that differs from the labeling on the outer box and sterilization bag. Ta. As a result of an investigation by Ospica, the overseas manufacturer, it was discovered that a different product had been mistakenly inserted during the manufacturing process. Therefore, we have decided to voluntarily recall the products from this lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: External pacemaker cables and adapters Sales name: Ospica External pacemaker relay cable |
| Manufacturer | Heiwa Bussan Co., Ltd. |
| Models | D2P-SP, P342142-08 |
| Date | Apr 14, 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