Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling the Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip (REF ECPMR0110G) because certain lot numbers and products were inadvertently not included in the scope of a previous recall. The original recall had been issued due to an increase in probe failures involving leaks, suction issues, and failure to obtain samples. This current recall affects lot number VTCW0468, which consists of 2,050 units that were distributed to numerous U.S. states and territories, as well as internationally to countries including Canada, Australia, and various European and Asian nations.
The affected product is a single-use, sterile, prescription medical device packaged individually in sterile pouches (5 pouches per carton). The record does not specify any remedy or corrective action for consumers who may have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Reason for recall: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. Distribution: Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zea Quantity: 2,050 units Lot/code info: Lot number VTCW0468; UDI number (01)00801741086304(17)200901(10)VTCW0468.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.