International safety notice
From the manufacturer Xmed S.R.L., the factory that performs the sterilization process (Steril Milano S.r.l.) We have been informed that a voluntary recall will be conducted because it cannot be ruled out that the product may have been sterilized in a manner that deviated from the specifications. If a product that has not been properly tested is used, the possibility of infection occurring after use cannot be ruled out. We will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · May 31, 2021
Key facts
| Title | From the manufacturer Xmed S.R.L., the factory that performs the sterilization process (Steril Milano S.r.l.) We have been informed that a voluntary recall will be conducted because it cannot be ruled out that the product may have been sterilized in a manner that deviated from the specifications. If a product that has not been properly tested is used, the possibility of infection occurring after use cannot be ruled out. We will carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Uterine manipulation set Brand name: EJ Uterus Manipulator |
| Manufacturer | Adachi Co., Ltd. |
| Models | 00635, 00633, 7060E, 00443, 9080E, 00765 |
| 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