Recall Z-1431-2020
Bard Peripheral Vascular Inc · initiated January 3, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Codes / lots: 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.
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.
FDA-determined cause: Component change control
Action taken
The recalling firm issued letters dated 1/3/2020 to each of the U.S. consignees via FedEx with proof of delivery notification. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-321-4254 Option #5.
Details
- Recall number
- Z-1431-2020
- Initiated
- January 3, 2020
- Terminated
- March 17, 2022
- Product code
- KNW – Instrument, Biopsy
- 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…
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1432-2020 Class II | Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-1433-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-1434-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |