Events

Rappel de Angiotech Breast Localization Needles

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medical Device Technologies, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54688
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2017-2010
  • Date de mise en oeuvre de l'événement
    2009-09-01
  • Date de publication de l'événement
    2010-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92379
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    needle, aspiration and injection, disposable - Product Code GAA
  • Cause
    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 Breast Localization Needles
  • Modèle / numéro de série
    A) 90621SZN, 91051TTN, 91591UV4, 90571SVW, 90571SVX, 90681T3E, 90911TK7, 91181TW9, 91271U9Y, 91561UU6, 90571SUJ, 90571SUK, 90681T46, 90831TA6, 90921TKY, 90961TLT, 91051TTS, 91131TZD, 91131U08, 91201U5P, 91471UNO, 91541US2, 91631UZT, 90891TGR, 90701T5A, 90961TM1, 91031TM2, 91341UF3, 91481UO9, 90751T6X, 90751T6Y, 91051TTL, 91131TZ7, 91541US1, 91551UT0, 90491SOM, 90821T2V, 91061TTU, 91121TXX, 91041TOI .   B) 90551STU, 91461ULZ, 91491UPP, 90551STT, 90681T42, 90921TKW, 90901TIZ, 91561UTY, 90541SRB, 91171TW7, 91311UBE, 90681T3N, 91311UBF, 91481UOA, 90541SS4, 90701T5G, 90971TOJ, 91171U2A, 91461UMQ, 90611SY7, 90891TH1, 91131TZT, 91471UNJ.   C) 91331UCJ, 90571SW1, 90641T1V, 91181U2T, 90551SUD, 90611SXX, 90901TJ3, 91271U9X, 91461UML, 90571SUV, 90821TCM, 90961TM3, 91411UKL, 90551SUE, 90641T1W, 90821TCN, 91061TUI, 91341UFK, 91461UMK, 91681V2T, 90611SXV, 90701T5M, 91131TZK, 91271U9V, 90641T22, 90681T39, 90681T3A, 90771T9T, 90821TCW, 90901TIK, 90971TNO, 91051TTT, 91271UA4, 91331UCR, 90551SU9, 90551SUA, 90571SVT, 90771TAE, 90891THJ, 91061TUP, 91331UCQ, 91471UNM, 91551UT2, 91741V6K.   D) 90411SIV, 90541SSU, 90641T1Y, 91131TZS, 90541SRF, 90631T0Z, 90751T7Q, 90841TEE, 91031TRX, 91271UA0, 91341UFS, 91391UHY, 90541SSD, 90781TBI, 90901TJA, 91271TUQ, 91491UPH, 91551UT3, 90901TJ8, 91561UU7, 90981TPU, 91131TZU.   E) 90611SYG, 91131TZB.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Angiotech Breast Localization Needles: || A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. || Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. || B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. || Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. || C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. || Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. || D) Homer Mammalok Gold Improved Tensile Strength. STERILE. || Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. || 510k Exempt. Qty Dist. - 21,780. || E) "D" Wire BLN. STERILE. || Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended use: Breast Localization Needle
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Adresse du fabricant
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Société-mère du fabricant (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA