International safety notice
During inspection at the manufacturing facility of this product, fibrous foreign matter was found attached. It has been confirmed that a manufacturing substance (polyester) used in the manufacturing process of We have decided to carry out a voluntary recall of lots for which we cannot deny that there is a risk of this occurring.
Japan / PMDA Recalls · JPN · Jul 8, 2024
Key facts
| Title | During inspection at the manufacturing facility of this product, fibrous foreign matter was found attached. It has been confirmed that a manufacturing substance (polyester) used in the manufacturing process of We have decided to carry out a voluntary recall of lots for which we cannot deny that there is a risk of this occurring. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use endoscopic non-active instrument for artificial openings Brand name: Disposable grasping forceps φ1.5 |
| Manufacturer | SB Kawasumi Co., Ltd. |
| Models | 40361001, 31161001, 40361002, MD-10100, 40161001, 31161003, 40161002, 31161002, 40361004 |
| Date | Jul 8, 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