Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
FDA device recall Z-1483-06 · posted 2006-09-02 · Terminated
Recall details
- Recalling firm
- Cordis Neurovascular, Inc.
- Reason for recall
- Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.
- Action taken
- All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 12 Lot numbers (14,161)
- Distribution
- Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
- Date initiated
- 2006-08-11
- Date posted
- 2006-09-02
- Date terminated
- 2008-11-25
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K021591) | Cordis Neurovascular, Inc. | 2002-05-22 |