International safety notice
"Ophthalmic needle Nipro disposable" manufactured by Nipro Co., Ltd., which is included in the kit product manufactured by our company. Regarding "intraocular injection needles," the manufacturer and distributor states that "adhesive is stuck in the needle tube of this product with a specific serial number." We received a report from Nipro Corporation. At the same time, we have received notification from Nipro Co., Ltd., the manufacturer and distributor, that they will be voluntarily recalling the product. We have decided to voluntarily recall our products.
Japan / PMDA Recalls · JPN · Dec 20, 2024
Key facts
| Title | "Ophthalmic needle Nipro disposable" manufactured by Nipro Co., Ltd., which is included in the kit product manufactured by our company. Regarding "intraocular injection needles," the manufacturer and distributor states that "adhesive is stuck in the needle tube of this product with a specific serial number." We received a report from Nipro Corporation. At the same time, we have received notification from Nipro Co., Ltd., the manufacturer and distributor, that they will be voluntarily recalling the product. We have decided to voluntarily recall our products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class III Treatment Kit Sales name: Ophthalmology kit |
| Manufacturer | Japan Medical Products Co., Ltd. |
| Models | 7573100, 456221, HP-E986, 455341, 455931, 455121, 455441, 455271, 454851, 7522300, HP-E1319, 456091 and 39 more |
| Date | Dec 20, 2024 |
| 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