International safety notice
This lead clipper is an optional accessory for the COOK lead extraction system, and is used to separate the lead wire and connector. This is a sterile, single-use instrument. Our company recently announced that the sterile packaging of the affected products may not meet quality standards until the expiry date and sterility cannot be guaranteed. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jul 18, 2023
Key facts
| Title | This lead clipper is an optional accessory for the COOK lead extraction system, and is used to separate the lead wire and connector. This is a sterile, single-use instrument. Our company recently announced that the sterile packaging of the affected products may not meet quality standards until the expiry date and sterility cannot be guaranteed. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Pacemaker/Defibrillator Lead Removal Kit Brand name: COOK lead removal system |
| Manufacturer | Cook Medical Japan LLC |
| Models | N186216, N189753, N180314, N193648, N179211, N190312, N187438, N176084, N191355, N178675, N174536, N194361 and 5 more |
| Date | Jul 18, 2023 |
| 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