Recall Z-0842-04 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Boston Scientific Corp
Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.
| Date | Jul 20, 2004 (initiated Mar 18, 2004) |
| Status | Terminated |
| Reason | Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr. |
| Root cause | Other |
| Action | Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product. |
| Quantity | 43 units |
| Distribution | Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.