Recall Z-1482-06 ยท KRA Catheter, Continuous Flush
Cordis Neurovascular, Inc.
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
| Date | Sep 2, 2006 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication. |
| Quantity | 15 Lot numbers (46,452) |
| Distribution | Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc., May 22, 2002 |