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U.S. Department of Health and Human Services

Class 2 Device Recall TLOK Bone Marrow Biopsy Needle

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 Class 2 Device Recall TLOK Bone Marrow Biopsy Needlesee related information
Date Initiated by FirmJuly 16, 2008
Date PostedJanuary 06, 2009
Recall Status1 Terminated 3 on April 21, 2009
Recall NumberZ-0452-2009
Recall Event ID 50156
510(K)NumberK980196 
Product Classification needle - Product Code KNW
ProductAngiotech, 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 2		Other
ActionEach 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 Commerce180 Units
DistributionNationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNW
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