| Date Initiated by Firm | August 09, 2004 |
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| Date Posted | September 14, 2004 |
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| Recall Status1 |
Terminated 3 on October 26, 2005 |
| Recall Number | Z-1445-04 |
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| Recall Event ID |
29795 |
| 510(K)Number | K840033 |
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| Product Classification |
Instrument, Biopsy - Product Code KNW
|
| Product | 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. |
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| Code Information |
6528009 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
|
| For Additional Information Contact | Marie Peters
508-652-5875 |
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Manufacturer Reason
for Recall | Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 27 cartons x 5 units |
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| Distribution | Products sold to 53 medical facilities nationwide and one consignee in Italy. |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = KNW
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