Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001P
FDA device recall Z-0847-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
- Action taken
- Letters dated 3/29/04 with instruction to remove and return product.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 72 units
- Date initiated
- 2004-03-29
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-13
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CATHETER INNOVATIONS IMPLANTABLE PORT (K991897) | Catheter Innovations, Inc. | 1999-10-21 |