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Class 2 Device Recall TLOK Bone Marrow Biopsy Needle |
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Date Initiated by Firm |
July 16, 2008 |
Date Posted |
January 06, 2009 |
Recall Status1 |
Terminated 3 on April 21, 2009 |
Recall Number |
Z-0452-2009 |
Recall Event ID |
50156 |
510(K)Number |
K980196
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Product Classification |
needle - Product Code KNW
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Product |
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy. |
Code Information |
Lot Number 81291N9Y |
Recalling Firm/ Manufacturer |
Medical Device Technologies, Inc. 3600 Sw 47th Ave Gainesville FL 32608-7555
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For Additional Information Contact |
352-338-0440 Ext. 350
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Manufacturer Reason for Recall |
Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
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FDA Determined Cause 2 |
Other |
Action |
Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance. |
Quantity in Commerce |
180 Units |
Distribution |
Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA. |
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 and Original Applicant = MEDICAL DEVICE TECHNOLOGIES, INC.
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