Recall Z-0759-04 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Boston Scientific Corporation
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.
| Date | Jul 20, 2004 (initiated Mar 5, 2004) |
| Status | Terminated |
| Reason | Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr. |
| Root cause | Other |
| Action | Letter dated 3/5/04 with instructions to return product. |
| Quantity | 75 units (box/10) |
| Distribution | 42 domestic hospitals nationwide and one distributor in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974640 | COAXIAL DILATOR SET Boston Scientific Corp, Mar 13, 1998 |