International safety notice
Recently, a foreign manufacturer has reported that the seal on the chevron seal of sterile packaging materials has opened, potentially impairing sterility. We have confirmed that. Therefore, we have decided to voluntarily recall products that use this material.
Japan / PMDA Recalls · JPN · Aug 15, 2022
Key facts
| Title | Recently, a foreign manufacturer has reported that the seal on the chevron seal of sterile packaging materials has opened, potentially impairing sterility. We have confirmed that. Therefore, we have decided to voluntarily recall products that use this material. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Brand name: COOK guide wire |
| Manufacturer | Cook Medical Japan LLC |
| Models | TSF-35-145, 14767453, 14808542, TSCF-35-80-3, 14809677, TSCF-35-145-15, THSF-35-145-AES-SGH, 14803101, 14833109, 14821852, 14814972, 14831160 and 1 more |
| Date | Aug 15, 2022 |
| 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