Recall Z-1444-04 ยท KNW Instrument, Biopsy
Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
| Date | Sep 14, 2004 (initiated Aug 9, 2004) |
| Status | Terminated |
| Reason | Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm. |
| Root cause | Other |
| Action | Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit. |
| Quantity | 22 cartons x 10 units |
| Distribution | Products sold to 53 medical facilities nationwide and one consignee in Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840033 | HYPODERMIC NEEDLES & STYLETS Microvasive, Apr 5, 1984 |