Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm dista
FDA device recall Z-0018-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Cordis Neurovascular, Inc.
- Reason for recall
- These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 54
- Distribution
- Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
- Date initiated
- 2001-10-19
- Date posted
- 2003-10-15
- Date terminated
- 2004-05-11
- 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 INFUSION CATHETERS WITH PRE-SHAPED TIPS (K003925) | Cordis Neurovascular, Inc. | 2001-01-08 |