Recalls / —
—#32088
Product
VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.
- FDA product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- 910482, 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 #32088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.