—#42603

Product

Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, MA and Boston Scientific, Glens Falls, NY

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K991897
Affected lot / code info: 1012596, 1020903

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 #42603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.