| Date Initiated by Firm | August 09, 2004 |
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| Date Posted | September 14, 2004 |
|---|
| Recall Status1 |
Terminated 3 on October 26, 2005 |
| Recall Number | Z-1444-04 |
|---|
| Recall Event ID |
29795 |
| 510(K)Number | K840033 |
|---|
| Product Classification |
Instrument, Biopsy - Product Code KNW
|
| Product | 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. |
|---|
| Code Information |
6528003, 6577339 |
| FEI Number |
3001451463
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Pl
Natick
MA
01760-1536
|
| For Additional Information Contact | Marie Peters
508-652-5875 |
|---|
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 | 22 cartons x 10 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 |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = KNW
|
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