International safety notice
Recently, a foreign manufacturer has confirmed that one lot of sterile packaging materials will meet quality standards until the expiration date. It was confirmed that the conditions were not met and sterility could not be guaranteed. We have decided to voluntarily recall products using these materials.
Japan / PMDA Recalls · JPN · Jul 15, 2022
Key facts
| Title | Recently, a foreign manufacturer has confirmed that one lot of sterile packaging materials will meet quality standards until the expiration date. It was confirmed that the conditions were not met and sterility could not be guaranteed. We have decided to voluntarily recall products using these materials. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Brand name: Cook Guide Wire (without heparin) |
| Manufacturer | Cook Medical Japan LLC |
| Models | RLPC-35-180, 14145419 |
| Date | Jul 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