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FDA (Device enforcement)Recalled 2020-01-03closedclass ii

Bard Peripheral Vascular Inc: Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

Is my product affected?

Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

  • UPC 00801741086328

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. is recalling 1,585 units of the Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip (REF ECPMR017G) distributed in the United States and internationally. The recall involves lot numbers VTCT0272 and VTCV0384 because these lots were inadvertently not included in the scope of a previous recall. The original recall was issued due to an increase in probe failures including leaks, suction issues, and failure to obtain samples.

The affected products were distributed to 30 U.S. states and the District of Columbia, as well as to Canada, Australia, and multiple European and Asian countries. The recall record does not specify a remedy or instructions for consumers to follow.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 1,585 units Lot/code info: Lot numbers VTCT0272 and VTCV0384. UDI numbers (01)00801741086328(17)200601(10)VTCT0272 and (01)00801741086328(17)200801(10)VTCV0384.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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