Device Recall

  • Modèle / numéro de série
  • Distribution
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA

22687 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    400 Test Kit Lot Number: 42462M100 and 100 Test Kit Lot Number: 42462M101
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Chile, Uruguay, Argentina, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
  • Description du dispositif
    ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.
  • Description du dispositif
    CELL-DYN 4000 Diluent/Sheath Reagent, || List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Manufacturer
  • Modèle / numéro de série
    Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
  • Description du dispositif
    MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, France, Germany, and United Kingdom.
  • Description du dispositif
    EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
  • Manufacturer
  • Modèle / numéro de série
    All serial numbers of Software Version 4.1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor)
  • Manufacturer
22682 en plus