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U.S. Department of Health and Human Services

Class 2 Device Recall Angiotech Soft Tissue Biopsy Needle Core

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  Class 2 Device Recall Angiotech Soft Tissue Biopsy Needle Core see related information
Date Initiated by Firm September 01, 2009
Date Posted July 13, 2010
Recall Status1 Terminated 3 on February 25, 2011
Recall Number Z-2016-2010
Recall Event ID 54688
510(K)Number K980226  
Product Classification instrument, biopsy - Product Code KNW
Product Angiotech Soft Tissue Biopsy Needle Core:

A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE.
Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880.

B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010.

C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550.

D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580.

MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A.

Intended use: Soft Tissue Biopsy Needle Core
Code Information A) 90831TDP, 90541SSA, 90501SQH, 90851TFJ, 91191U4R, 91391UI0, 90751T73, 91391UHQ, 90771T9L, 90851TFL, 90551SU0, 90551SU1, 90611SYJ, 90761T8Y, 90771TAH, 90781TBL, 90831TDY, 90911TK9, 91121TWT, 91271UA6, 91341UET, 91391UHN, 91481UNX, 91491UPN, 91661V0I, 91691V3D, 91761V94, 90541SSM, 90551STX, 90681T3H, 90701T58, 91171U1C, 91321UAQ, 91481UNY, 91821VDX, 90751T7Z, 90831TDW, 90991TR4, 90991TR5, 91031TR6, 91321UB8, 91661V0O, 90481SO1, 90621T04, 90621T05, 90901TJ7, 91121TY1, 91131U0J, 91171U1V, 91381UH2.   B) 90541SRD, 90611SXP, 90981TQ5, 90971TNX, 90971TO1.   C) 90551STO, 90681T40, 90821TCS, 90901TIY, 90911TK8, 91261U8B, 91261U8C, 91271U9A, 91381UGH, 91821VDG, 91821VDH, 91821VDI, 91821VDJ, 90771TA7, 90781TB2, 91181U2M, 90501SQI, 90921TKO, 90761T8U, 90901TIN, 91181U32, 91401UJ9, 91741V7S .   D) 91271U9J, 90681T31.  
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		 Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.
FDA Determined
Cause 2		 Other
Action Angiotech sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated September 1, 2009, to all customers. on September 2, 2009 by UPS 2nd day delivery with an assigned tracking number. The letter described the product, problem and action to be taken by customers. The customers were instructed to please review your current inventory and segregate the affected lot numbers, complete the attached Customer Acknowledgement Form and return via fax to our Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you are a distributor of this product, you are responsible for notifying any customer you may have sold the product to. If you have any questions concerning this notification, please contact Shannon Brooks at (352) 338-0440 ext.355 or Katrenia Williams at ext. 353.
Quantity in Commerce 52,020
Distribution Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
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.
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