International safety notice
At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process for this product, certain product lots undergo the sterilization process. It was confirmed that there were deficiencies in the records, and it became clear that the sterility assurance level required for medical devices could not be guaranteed. In response to this information, we are voluntarily recalling this product because we cannot confirm the validity of the manufacturing process for this product.
Japan / PMDA Recalls · JPN · Nov 16, 2021
Key facts
| Title | At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process for this product, certain product lots undergo the sterilization process. It was confirmed that there were deficiencies in the records, and it became clear that the sterility assurance level required for medical devices could not be guaranteed. In response to this information, we are voluntarily recalling this product because we cannot confirm the validity of the manufacturing process for this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Medical cotton tape Sales name: (1) Flock swab 534CS01 (2) Flock swab N100 (3) Flock swab TR80 (4) Flock swab 534C (5) Flock swab TN100 (6) Flock swab U80 |
| Manufacturer | Techno Amenity Co., Ltd. |
| Models | 1816440, 534CS01, 525CS01, 1816438, 1814763, 2009380, 1801588, 1817636, 503CS01 |
| Date | Nov 16, 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