Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-2888-2018

CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

Publicado el 29 de agosto de 2018 · Inicio del retiro: 23 de febrero de 2018

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Civco Medical Instruments Co. Inc.
Distribuidor
Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
Lote
Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110, M119380, M605540, M706720, M570610, M543670, M851530, M983170, M358570. M358570, M427660. M526300, M526300, M734570, M912740, and M664690. Item 698-009: Biopsy Starter Kit for use with Zonare C9-3 transducers M427370, M103030, A010473, M103030, M771190, M427390, M293590, M427370, M105150, M089260, M515370, M293580, M888920, M427370, M220960, M558420, M560740, M909270, M096330, M388690, M558220, M695400, M085550, M917410, M419650, M879530, M964370, M093020, M723180, and A010459 Item: 698-016 Biposy Bracket for use with Zonare C9-3 transducers M567620 and M052860 Item 620-116 Biopsy Starter Kit for use with BK Medical 18L5 and 8870 transducers M080890, M559550, M425050, M056610, M092800, M041630, M186540, M122250, M335740, M043310, M499390, M483250, M109060, M275630, M912150, A023904, M457560, M051670, M091360, M895560, A015235, M202260, M869430, M056610, M027090, M308820, M831280, M547370, M253050, M083160, and M865470
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta