International safety notice
Ethylene oxide sterilization has been verified at the manufacturing facility (Steril Milano S.r.l.) outsourced to the sterilization process of the device. We have received notification from an overseas manufacturer of a possible deviation from parameters. loaded As a result of checking the details such as the sterilization completion verification status of the products, we found that the sterility of the specific lot products could not be verified. Kina As a result, we decided to conduct a voluntary recall of these lot numbers.
Japan / PMDA Recalls · JPN · Jun 9, 2021
Key facts
| Title | Ethylene oxide sterilization has been verified at the manufacturing facility (Steril Milano S.r.l.) outsourced to the sterilization process of the device. We have received notification from an overseas manufacturer of a possible deviation from parameters. loaded As a result of checking the details such as the sterilization completion verification status of the products, we found that the sterility of the specific lot products could not be verified. Kina As a result, we decided to conduct a voluntary recall of these lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Breathing circuit set (2) Connector for single-use breathing circuit (3) Artificial nose (4) Artificial nose for tracheostomy patients (5) Bronchial suction catheter Sales name: (1-1) DAR air filter (1-2) DAR disposable breathing circuit parts (2) DAR breathing system (3) DAR artificial nose (4) DAR spontaneous breathing artificial nose (5) Thai Care |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | 20D0376FAX, 19A1419FAX, 19C0237FAX, 19A0291FAX, 19D0516FAX, 19C0133FAX, 19A1265FAX, 19F0615FAX, 19E0406FAX, 19F0649FAX, 19D0804FAX, 19G1300FAX and 476 more |
| Date | Jun 9, 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