FDA Device Recall Z-0044-2018: Bard Peripheral Vascular Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2018.

Recall Res Number

Z-0044-2018

Recalling Firm / Manufacturer

Bard Peripheral Vascular Inc

FEI Number

2020394

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-09-22

Date Posted

N/A

Date Terminated

2018-09-27

Product Code

KNW

Event Number

78224

Product Quantity

110,550 units

Product Description 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 for Recall 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.

Action Details BPV sent a customer recall letter on September 22, 2017 to each of the US consignees via FedEx with proof of delivery notification. BPV will also initiate a recall for product outside the US in accordance with regulations of each country in which the product was distributed.

Distribution Pattern US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0044-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer