Class 2 Device Recall TLOK Bone Marrow Biopsy Needle

• Date Initiated by Firm: July 16, 2008
• Date Posted: January 06, 2009
• Recall Status: Terminated on April 21, 2009
• Recall Number: Z-0452-2009
• Recall Event ID: 50156
• 510(K)Number: K980196
• Product Classification: needle - Product Code KNW
• 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
• For Additional Information Contact: 352-338-0440 Ext. 350
• Manufacturer Reason for Recall: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
• FDA Determined Cause: 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

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 and Original Applicant = MEDICAL DEVICE TECHNOLOGIES, INC.