Devices

Device Recall i STAT

  • Model / Serial
    Lot Number -- Expiration Date:  U06024B -- exp. date 09/14/06; U06037C -- exp. date 09/28/06; U06062A -- exp. date 10/28/06; U06063 -- exp. date 10/28/06.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide ---There is only one US customer for these lots. The rest are international customers (Germany, Turkey, Hong Kong, Japan, Canada). There are no government accounts.
  • Product Description
    i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. || i-STAT Catalog Number -- 220300; || Abbott List Number (US and Canada)-- 06F01-01; || Abbott List Number (Rest of World) -- 06F01-02.
  • Manufacturer
    Abbott Laboratories
  • 1 Event

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA