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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0724-2020

BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Publicado el 1 de enero de 2020 · Inicio del retiro: 25 de octubre de 2019

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

During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Bard Peripheral Vascular Inc
Distribuidor
Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific.
Lote
Device Listing: D222541 Product Code/Lot Number/UDI MC1410 - 114g x10cm RECN0753/(01)00801741084423(17)201231(10)RECN0753 REDR1996/(01)00801741084423(17)220331(10)REDR1996 REDS0461/(01)00801741084423(17)220331(10)REDS0461 MC1416 - 14 g x 16 cm RECP1763/(01)00801741084430(17)210228(10)RECP1763 MC1610 - 16 g x 10 cm RECN0756/(01)00801741084447(17)201231(10)RECN0756 RECN1632/(01)00801741084447(17)201231(10)RECN1632 REDN2403/(01)00801741084447(17)211231(10)REDN2403 REDN2448/(01)00801741084447(17)211231(10)REDN2448 REDN3426/(01)00801741084447(17)211231(10)REDN3426 REDP0046/(01)00801741084447(17)211231(10)REDP0046 REDQ2463/(01)00801741084447(17)220228(10)REDQ2463 REDR1997/(01)00801741084447(17)220331(10)REDR1997 REDS1470/(01)00801741084447(17)220430(10)REDS1470 REDS2663/(01)00801741084447(17)220430(10)REDS2663 REDS3864/(01)00801741084447(17)220430(10)REDS3864 REDS4214/(01)00801741084447(17)220430(10)REDS4214 REDT1884/(01)00801741084447(17)220531(10)REDT1884 REDT4419/(01)00801741084447(17)220531(10)REDT4419 REDU1687/(01)00801741084447(17)220630(10)REDU1687 REDU2579/(01)00801741084447(17)220630(10)REDU2579 MC1616 - 16 g x 16 cm RECN2119/(01)00801741084454(17)210131(10)RECN2119 RECP2400/(01)00801741084454(17)210228(10)RECP2400 REDN2402/(01)00801741084454(17)211231(10)REDN2402 REDN2447/(01)00801741084454(17)211231(10)REDN2447 REDN3457/(01)00801741084454(17)211231(10)REDN3457 REDP0085/(01)00801741084454(17)211231(10)REDP0085 REDQ2460/(01)00801741084454(17)220228(10)REDQ2460 REDQ4100/(01)00801741084454(17)220228(10)REDQ4100 REDR0746/(01)00801741084454(17)220331(10)REDR0746 REDR2055/(01)00801741084454(17)220331(10)REDR2055 REDS0420/(01)00801741084454(17)220331(10)REDS0420 REDS1471/(01)00801741084454(17)220430(10)REDS1471 REDS2594/(01)00801741084454(17)220430(10)REDS2594 REDS2595/(01)00801741084454(17)220430(10)REDS2595 REDS2664/(01)00801741084454(17)220430(10)REDS2664 REDS3750/(01)00801741084454(17)220430(10)REDS3750 REDT0879/(01)00801741084454(17)220531(10)REDT0879 REDT2007/(01)00801741084454(17)220531(10)REDT2007 REDT3043/(01)00801741084454(17)220531(10)REDT3043 REDU0929/(01)00801741084454(17)220630(10)REDU0929 REDU3571/(01)00801741084454(17)220630(10)REDU3571 REDU4536/(01)00801741084454(17)220630(10)REDU4536 REDV1435/(01)00801741084454(17)220731(10)REDV1435 REDV2354/(01)00801741084454(17)220731(10)REDV2354 MC1810 - 18 g x 10 cm RECN2069/(01)00801741084461(17)210131(10)RECN2069 REDN0266/(01)00801741084461(17)211231(10)REDN0266 REDN1612/(01)00801741084461(17)211231(10)REDN1612 REDN3443/(01)00801741084461(17)211231(10)REDN3443 REDP0047/(01)00801741084461(17)211231(10)REDP0047 REDP2162/(01)00801741084461(17)220131(10)REDP2162 REDP3393/(01)00801741084461(17)220131(10)REDP3393 REDP4637/(01)00801741084461(17)220131(10)REDP4637 REDQ0871/(01)00801741084461(17)220228(10)REDQ0871 REDQ2499/(01)00801741084461(17)220228(10)REDQ2499 REDQ2502/(01)00801741084461(17)220228(10)REDQ2502 REDR0676/(01)00801741084461(17)220331(10)REDR0676 REDR1998/(01)00801741084461(17)220331(10)REDR1998 REDS0469/(01)00801741084461(17)220331(10)REDS0469 REDS1610/(01)00801741084461(17)220430(10)REDS1610 REDS2665/(01)00801741084461(17)220430(10)REDS2665 REDS3865/(01)00801741084461(17)220430(10)REDS3865 REDS4215/(01)00801741084461(17)220430(10)REDS4215 REDT0926/(01)00801741084461(17)220531(10)REDT0926 REDT1885/(01)00801741084461(17)220531(10)REDT1885 REDT4420/(01)00801741084461(17)220531(10)REDT4420 REDU0922/(01)00801741084461(17)220630(10)REDU0922 REDU2476/(01)00801741084461(17)220630(10)REDU2476 REDU3498/(01)00801741084461(17)220630(10)REDU3498 REDU4566/(01)00801741084461(17)220630(10)REDU4566 REDV1369/(01)00801741084461(17)220731(10)REDV1369 REDV3016/(01)00801741084461(17)220731(10)REDV3016 MC1816 - 18 g x 16 cm RECZ2179/(01)00801741084478(17)211130(10)RECZ2179 RECZ3084/(01)00801741084478(17)211130(10)RECZ3084 RECZ3178/(01)00801741084478(17)211130(10)RECZ3178 REDN2401/(01)00801741084
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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