Bard Biopsy EnCor Probe recall
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx…
Why was Bard Biopsy EnCor Probe recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx…
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 12,875 units
- 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 Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)