Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, 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 1,085 units of the Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip (Reference number ECPMR0110GBT) from Lot number VTCV0370. These sterile, single-use biopsy probes were inadvertently not included in the scope of a previous recall. The original recall was issued due to an increase in probe failures involving leaks, suction issues, and failure to obtain samples.
The affected devices were distributed to 29 U.S. states and multiple countries including Canada, Australia, and various European and Asian nations. The recall does not specify what action consumers or healthcare providers should take regarding the recalled units.
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: 1,085 units Lot/code info: Lot number VTCV0370; UDI number (01)00801741086311(17)200801(10)VTCV0370.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.