—#39488

Product

PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, 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: K963806
Affected lot / code info: 934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.

Why it was recalled

Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.

Root cause (FDA determination)

Other

Action the firm took

Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: 278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.

Timeline

Recall initiated: 2004-05-25
Posted by FDA: 2005-08-10
Terminated: 2006-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39488. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.