Cordis Neurovascular, Inc.
Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
| Date | Oct 15, 2003 (initiated Oct 19, 2001) |
| Status | Terminated |
| Reason | These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray. |
| Root cause | Other |
| Action | The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved. |
| Quantity | 54 |
| Distribution | Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003925 | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS Cordis Neurovascular, Inc., Jan 8, 2001 |