Devices

Device Recall

Manufacturer

Windstone Medical, Inc.
  • Manufacturer Address
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA

22687 devices with a similar name

Learn more about the data here

Device Recall ARCHITECT Estradiol Reagent
  • Model / Serial
    400 Test Kit Lot Number: 42462M100 and 100 Test Kit Lot Number: 42462M101
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
    Abbott Laboratories
Device Recall CELLDYN 4000
  • Model / Serial
    Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
    Abbott Laboratories
Device Recall MicroMaxx LAP Transducer
  • Model / Serial
    Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
  • Product Description
    MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
  • Manufacturer
    Sonosite, Inc.
Device Recall EpiFix
  • Model / Serial
    Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, France, Germany, and United Kingdom.
  • Product Description
    EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
  • Manufacturer
    Merit Medical Systems, Inc
Device Recall CIC Pro System
  • Model / Serial
    All serial numbers of Software Version 4.1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    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
    General Electric Medical Systems Information Technology
22682 more