International safety notice
The content of the manufacturing and sales notification for this product is considered to be outside the scope of the definition of medical cotton swabs for the following reasons: Therefore, we decided to collect it. (1) "Purpose of Use, Efficacy, or Effect" states that "This product is a hair-type end finger of a hair-type thoracoscopic surgical instrument or a hair-type cotton." There is a sentence that is not included in the definition of a medical swab, such as ``used as a cotton swab exclusively for fingers.'' (2) The brand name suggests use in thoracoscopic surgery.
Japan / PMDA Recalls · JPN · May 31, 2021
Key facts
| Title | The content of the manufacturing and sales notification for this product is considered to be outside the scope of the definition of medical cotton swabs for the following reasons: Therefore, we decided to collect it. (1) "Purpose of Use, Efficacy, or Effect" states that "This product is a hair-type end finger of a hair-type thoracoscopic surgical instrument or a hair-type cotton." There is a sentence that is not included in the definition of a medical swab, such as ``used as a cotton swab exclusively for fingers.'' (2) The brand name suggests use in thoracoscopic surgery. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Medical cotton tape Sales name: (1) Soraco Cotton Large 2K70-7101 (2) Soraco Cotton Small 2K70-7102 (3) Soraco Cotton Large 4K70-7105 (4) Soraco Cotton Small 4K70-7106 (5) Soraco cotton thin 4K70-7108 |
| Manufacturer | Japan Cotton Swab Co., Ltd. |
| Date | May 31, 2021 |
| 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