FDA Recall
Terminated
Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
Recall: Z-0847-04
·
Initiated March 29, 2004
Recall
- Recall Number
- Z-0847-04
- Event Number
- 28675
- Firm
- Boston Scientific Corporation
- FEI Number
- 3001451463
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 29, 2004
- Posted
- July 20, 2004
- Terminated
- October 13, 2005
- Address
- 1 Boston Scientific Pl, Natick, MA, 01760-1536
Description
Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
Reason
Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
Action
Letters dated 3/29/04 with instruction to remove and return product.
Quantity
72 units