International safety notice
As of June 18, 2021, we conducted a voluntary recall for the same reason, and as a result of an internal investigation, we found that It has also been discovered that the sterilization method used by the component supplier for three-way stopcocks has been changed from gamma rays to electron beams. Ta. We have decided to voluntarily recall the affected products that contain the components concerned.
Japan / PMDA Recalls · JPN · Aug 4, 2021
Key facts
| Title | As of June 18, 2021, we conducted a voluntary recall for the same reason, and as a result of an internal investigation, we found that It has also been discovered that the sterilization method used by the component supplier for three-way stopcocks has been changed from gamma rays to electron beams. Ta. We have decided to voluntarily recall the affected products that contain the components concerned. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class IV Treatment Kit Sales name: (1) Angio kit (2) General surgery kit (3) Simple treatment kit (4) Thoracic surgery kit (5) Orthopedic surgery kit (6) Brain surgery kit (7) Urology kit |
| Manufacturer | Hogy Medical Co., Ltd. |
| Models | 8720455522, 14390107T4, 0120455451, 8720451809, 9Y20456131, 9139010A80, 0120450545, 9Z20451746, 1339010CS2, 558323382616, 558343749306, 89390102GP and 545 more |
| Date | Aug 4, 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