Recalls / —
—#42599
Product
Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.
- FDA product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K962300
- Affected lot / code info
- 1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952
Why it was recalled
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
Root cause (FDA determination)
Other
Action the firm took
Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536
Distribution
- Distribution pattern
- DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
Timeline
- Recall initiated
- 2005-10-28
- Posted by FDA
- 2006-01-06
- Terminated
- 2007-02-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #42599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.