International safety notice
It was discovered that some products in the manufacturer's inventory had 0.2-0.5mm pieces of product mixed into their sterilized packaging. A detailed investigation by the manufacturer revealed that the product pieces had product-derived burrs that occurred during the molding process of a specific manufacturing lot. It was determined that the product had been mixed into the packaging. We have decided to carry out a collection.
Japan / PMDA Recalls · JPN · Mar 3, 2022
Key facts
| Title | It was discovered that some products in the manufacturer's inventory had 0.2-0.5mm pieces of product mixed into their sterilized packaging. A detailed investigation by the manufacturer revealed that the product pieces had product-derived burrs that occurred during the molding process of a specific manufacturing lot. It was determined that the product had been mixed into the packaging. We have decided to carry out a collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electric endoscope lens cleaner Brand name: Endoscope lens cleaner OpClear (OpClear disposable) |
| Manufacturer | Amco Co., Ltd. |
| Models | CS-SZ10-30, 10mm×30°, CS-SZ10-00, 10mm×0° |
| Date | Mar 3, 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