International safety notice
We are pleased to inform you that the label of a particular lot of Cook Approach Hydro ST Guidewire has been used for a longer period of time than originally intended. Since we confirmed that the expiration date was displayed, we decided to voluntarily recall the products in question.
Japan / PMDA Recalls · JPN · Oct 3, 2024
Key facts
| Title | We are pleased to inform you that the label of a particular lot of Cook Approach Hydro ST Guidewire has been used for a longer period of time than originally intended. Since we confirmed that the expiration date was displayed, we decided to voluntarily recall the products in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Brand name: Cook Approach Hydro ST Guidewire |
| Manufacturer | Cook Medical Japan LLC |
| Models | HMW-14-300-ST, 15885580, HMW-14-190-ST, 15778260, 15879455, 15811656, 15726044, 15765952, 15778257, 15831159 |
| Date | Oct 3, 2024 |
| 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