International safety notice
Regarding the "Nipro disposable intraocular injection needle" (medical device), which is a component of the kit product manufactured and sold by our company, We received a report from Nipro Co., Ltd., the manufacturer and distributor, that the needle tube was clogged and could not be used, and as a result of an investigation, we found that It was discovered that the needle tube of this product with a certain serial number was clogged with adhesive, and a voluntary recall of the product was announced. I have been contacted. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Dec 23, 2024
Key facts
| Title | Regarding the "Nipro disposable intraocular injection needle" (medical device), which is a component of the kit product manufactured and sold by our company, We received a report from Nipro Co., Ltd., the manufacturer and distributor, that the needle tube was clogged and could not be used, and as a result of an investigation, we found that It was discovered that the needle tube of this product with a certain serial number was clogged with adhesive, and a voluntary recall of the product was announced. I have been contacted. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class III Treatment Kit Sales name: Medline Surgical Custom Kit for Ophthalmology |
| Manufacturer | Medline Japan LLC |
| Models | M31OPH003D, M12OPH008E, KT2419960, KT2420432, M12OPH005D, KT2419411, KT2419462, KT2419239, M01OPH010D, KT2419603, KT2419336, M12OPH006E and 1 more |
| Date | Dec 23, 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