International safety notice
We have received reports of leaks occurring from the lock adapter part of the product in a specific lot. As a result, a defect was confirmed in some of the molds during the molding process at our overseas manufacturing factory, and some products included damaged connectors. We have decided to take voluntary recall measures as we have discovered that there is a possibility that the product may have been compromised.
Japan / PMDA Recalls · JPN · Jun 20, 2022
Key facts
| Title | We have received reports of leaks occurring from the lock adapter part of the product in a specific lot. As a result, a defect was confirmed in some of the molds during the molding process at our overseas manufacturing factory, and some products included damaged connectors. We have decided to take voluntary recall measures as we have discovered that there is a possibility that the product may have been compromised. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Stopcock for infusion pumps Brand name: Connector three-way stopcock |
| Manufacturer | Nippon Becton Dickinson Co., Ltd. |
| Models | 1214380, 1061528, 1154844, 394900, 394910 |
| Date | Jun 20, 2022 |
| 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