—#40678

Product

Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK Catalog Number: CVC961IK

FDA product code: KOB — Catheter, Suprapubic (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K962300
Affected lot / code info: Lot Numbers: 970797 975780 976519 984496 991184 1012876 1014484 1015393 1017361 1018981 1019389 1019740 1025515 1028107 1029092

Why it was recalled

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Recalling firm

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

Distribution

Distribution pattern: Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula

Timeline

Recall initiated: 2005-07-22
Posted by FDA: 2005-09-02
Terminated: 2007-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.