Recall Z-0044-2018
Bard Peripheral Vascular Inc · initiated September 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0044-2018
- Initiated
- September 22, 2017
- Terminated
- September 27, 2018
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 110,550 units
- Distribution
- US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ