Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
FDA Recall Z-1445-04 · Posted 2004-09-14
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKNW
Date Initiated2004-08-09
Date Terminated2005-10-26
Product Quantity27 cartons x 5 units
Reason for Recall
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
Firm 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.
Root Cause
Other
Distribution Pattern
Products sold to 53 medical facilities nationwide and one consignee in Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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