Recall Z-1104-04 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Boston Scientific Corp
Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.
| Date | Jul 20, 2004 (initiated Jun 16, 2004) |
| Status | Terminated |
| Reason | Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa. |
| Root cause | Other |
| Action | Recall letters dated June 16, 2004 were sent to consignees requesting product return. |
| Quantity | 1840 |
| Distribution | Nationwide and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.