FDAFDA · Food and drugs·Recall number Z-0290-2016
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Published November 25, 2015 · Recall initiated: October 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of the product cannot be assured.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Distributor
- Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.
- Lot
- M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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