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U.S. Department of Health and Human Services

Class 2 Device Recall BioPince

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  Class 2 Device Recall BioPince see related information
Date Initiated by Firm March 02, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 07, 2012
Recall Number Z-0952-04
Recall Event ID 29023
510(K)Number K904987A  
Product Classification Needle, Aspiration And Injection, Disposable - Product Code GAA
Product BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot
Code Information PART NUMBER LOT NUMBER 360-1080-01 24821 360-1080-01 30531 360-1080-01 30811 360-1080-01 30923 360-1080-02 24821 360-1080-01 31251 360-1080-01 32211 360-1080-01 32842 360-1080-01 32851-1 360-1080-01 32851-2 360-1080-01 33451 360-1080-01 33452 360-1080-01 33832 360-1080-01 34031 360-1080-01 34331 360-1080-01 34512 360-1080-01 34721 360-1580-01 30633 360-1580-01 31042 360-1580-01 32032 360-1580-01 32341 360-1580-01 32852 360-1580-01 33433 360-1580-01 33434 360-1580-01 34232 360-1580-01 34931 360-1580-01 32852-2 360-2080-01 30751 360-2080-01 30811 360-2080-01 31531 360-2080-01 33331 360-2080-01 33332 360-2080-01 34221 360-2080-01 34322 360-2080-01 34734 360-2080-01 34941 363-1080-01 32431 364-1080-01 34549 364-1580-01 34432 370-1080-01 33932 370-1080-01 35032 370-1580-01 34447 370-1580-01 35021            
Recalling Firm/
Manufacturer		 Medical Device Technologies, Inc.
3600 SW 47th Ave
Gainesville FL 32608-7555
For Additional Information Contact Karl Swartz
352-338-0440 Ext. 350
Manufacturer Reason
for Recall		 The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.
FDA Determined
Cause 2		 Other
Action The firm mailed a recall letter to accounts on 3/2/2004 asking each account to inspect their in stock product for damage and to to notify the recalling firm and return product. Also the firm enclosed a response card in a self addressed postage paid envelope.
Quantity in Commerce 10,303
Distribution The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.
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.
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