VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry n
FDA device recall Z-0759-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
- Action taken
- Letter dated 3/5/04 with instructions to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 75 units (box/10)
- Distribution
- 42 domestic hospitals nationwide and one distributor in Canada.
- Date initiated
- 2004-03-05
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-26
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAXIAL DILATOR SET (K974640) | Boston Scientific Corp | 1998-03-13 |