Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, 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 12,875 units of the Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G (reference number ECP017G) due to certain lot numbers that were inadvertently not included in a previous recall. The original recall was issued because of an increase in probe failures involving leaks, suction issues, and failure to obtain samples. The affected lots are VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, and VTCU0341. These products were distributed to healthcare facilities across 29 U.S. states plus Washington D.C., as well as internationally to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, the Netherlands, and New Zealand.
The recall affects sterile, single-use biopsy probes packaged individually in sterile pouches (5 pouches per carton). The source document does not specify a remedy or corrective action for affected consumers or healthcare facilities.
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: 12,875 units Lot/code info: Lot numbers VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, and VTCU0341. UDI numbers: (01)00801741086281(17)200601(10)VTCT0268, (01)00801741086281(17)200601(10)VTCT0269, (01)00801741086281(17)200601(10)VTCT0270, (01)00801741086281(17)200601(10)VTCT0271, (01)00801741086281(17)200601(10)VTCU0340, and (01)00801741086281(17)200601(10)VTCU0341.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.