—#32085

Product

VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.

FDA product code: DRE — Dilator, Vessel, For Percutaneous Catheterization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K974640
Affected lot / code info: 912502, Exp. 10/31/05

Why it was recalled

Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

Root cause (FDA determination)

Other

Action the firm took

Letter dated 3/5/04 with instructions to return product.

Recalling firm

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

Distribution

Distribution pattern: 42 domestic hospitals nationwide and one distributor in Canada.

Timeline

Recall initiated: 2004-03-05
Posted by FDA: 2004-07-20
Terminated: 2005-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.