International safety notice
At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process for this product, a specific product lot undergoes a sterilization process. It was confirmed that there were record deficiencies, and it became clear that the sterility assurance level required for medical devices could not be guaranteed. In response to this information, we are unable to confirm the validity of the manufacturing process for this product, so we are voluntarily recalling the product.
Japan / PMDA Recalls · JPN · Oct 28, 2021
Key facts
| Title | At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process for this product, a specific product lot undergoes a sterilization process. It was confirmed that there were record deficiencies, and it became clear that the sterility assurance level required for medical devices could not be guaranteed. In response to this information, we are unable to confirm the validity of the manufacturing process for this product, so we are voluntarily recalling the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Medical cotton tape Sales name: (1)Ex Swab 001 (2)Ex swab 002 (3)Ex swab 002T |
| Manufacturer | Denka Co., Ltd. |
| Models | 0678101, 0319111, 0089011, 323996, 325280, 324009 |
| Date | Oct 28, 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