Z-0044-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- September 22, 2017
- Termination Date
- September 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
Distribution Pattern
US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
Code Information
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