Recall Z-1443-04 ยท KNW Instrument, Biopsy
Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (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 | 48 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
| K813462 | MADAYAG TYPE NEEDLE Ocean Medical Products, Ltd., Mar 1, 1982 |