International safety notice
Cooke embolization coils are supplied with the coil pre-installed within the coil inserter. It is a product that Certain lot numbers of some product numbers may be contaminated with hollow cylinders. We have decided to voluntarily recall the items.
Japan / PMDA Recalls · JPN · May 10, 2022
Key facts
| Title | Cooke embolization coils are supplied with the coil pre-installed within the coil inserter. It is a product that Certain lot numbers of some product numbers may be contaminated with hollow cylinders. We have decided to voluntarily recall the items. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Prosthetic material for promoting embolization in blood vessels of the central circulatory system Sales name: Cook Embolization Coil |
| Manufacturer | Cook Medical Japan LLC |
| Models | 14405358, 14212801, 14220595, MWCE-18S-2, 14311202, 14202556, 14394810, 14381231, 14468460, 14198998, 14438131, 14467340 and 92 more |
| Date | May 10, 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