—#34543

Product

Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K813462
Affected lot / code info: 6503654, 6513396, 6544512

Why it was recalled

Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: Products sold to 53 medical facilities nationwide and one consignee in Italy.

Timeline

Recall initiated: 2004-08-09
Posted by FDA: 2004-09-14
Terminated: 2005-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.