FDA Device recall Z-0044-2018
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm
- FDA Device
- Class II
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class II recall of BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm by Bard Peripheral Vascular, citing during the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, F….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0044-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-22 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | n/a |
Product
BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Reason
During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
Identifiers
| code_info | Lot Numbers: REBP0019, REBN0342, REBN2123, REBP1199, REBP1419, REBP1807, REBQ0084, REBQ0343, REBQ1012, REBP1420, REBP18…Lot Numbers: REBP0019, REBN0342, REBN2123, REBP1199, REBP1419, REBP1807, REBQ0084, REBQ0343, REBQ1012, REBP1420, REBP1809, REBP0869, REBP1266, REBP1267, REBP1421, REBP1422, REBP1810, REBQ0087, REBQ0088, REBQ0347, REBQ0811, REBQ1014, REBP0158, REBQ1904, REBQ1898, REBQ1978, REBR0468, REBQ2296, REBR0474 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2018%22
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