Events

Recall of Angiotech Soft Tissue Biopsy Needle Core

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Device Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54688
  • Event Risk Class
    Class 2
  • Event Number
    Z-2016-2010
  • Event Initiated Date
    2009-09-01
  • Event Date Posted
    2010-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92378
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    instrument, biopsy - Product Code KNW
  • Reason
    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.
  • 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.

Device

Angiotech Soft Tissue Biopsy Needle Core
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Manufacturer Address
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Manufacturer Parent Company (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA