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.
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling approximately 727,034 units of its BARD MAX-CORE Disposable Core Biopsy Instrument worldwide, including distribution throughout the United States and countries in Australia, Canada, Europe, the Middle East, Africa, Latin America, and Asia Pacific. The recall was initiated after the company observed a significant increase in complaints during May 2019 regarding the devices failing to fire, experiencing firing problems, or failing to obtain tissue samples. The affected devices are core needle biopsy instruments used to obtain tissue samples from soft tissues such as the liver, and the recall involves multiple lot numbers across several product configurations, including MC1410, MC1416, MC1610, and MC1616 models with expiration dates ranging from December 2020 through June 2022.
The source document does not specify any remedy or instructions for affected consumers regarding what actions they should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific. Quantity: 727,034 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.