FDA Device recall Z-0724-2020
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies fr…
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies fr… by Bard Peripheral Vascular, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0724-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-25 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Device Listing: D222541 Product Code/Lot Number/UDI MC1410 - 114g x10cm RECN0753/(01)00801741084423(17)201231(10)R…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 REDT44 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2020%22
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