International safety notice
Manufactured by the target product (sales name: VIZIGO sheath, product number: D138502, curve diameter: 22mm, lot number: 50000224) When I opened the product box, I found that the sterilized packaging and product itself were different (VIZIGO sheath, product number: D138501, carton). We have received a report from a medical institution that the product was contaminated with the product (diameter: 17mm, lot number: 00002137). Because there is a possibility that the wrong product may have been inserted, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Feb 28, 2023
Key facts
| Title | Manufactured by the target product (sales name: VIZIGO sheath, product number: D138502, curve diameter: 22mm, lot number: 50000224) When I opened the product box, I found that the sterilized packaging and product itself were different (VIZIGO sheath, product number: D138501, carton). We have received a report from a medical institution that the product was contaminated with the product (diameter: 17mm, lot number: 00002137). Because there is a possibility that the wrong product may have been inserted, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Cardiac Catheter Introducer Kit Sales name: VIZIGO sheath |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | 00002137, 50000224, D138502, D138501 |
| Date | Feb 28, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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