Z-1432-2020Class II

Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches...

Name: Z-1432-2020 Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches...
Creator: Bard Peripheral Vascular Inc
Published: 2020-01-03
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2020-01-03 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile on 2020-01-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1432-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-03-03
Terminated: 2022-03-17
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Product code: KNW Instrument, Biopsy
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 root cause: Component change control
Action: 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.
Quantity in commerce: 1,585 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.
Product codes and lots: Lot numbers VTCT0272 and VTCV0384. UDI numbers (01)00801741086328(17)200601(10)VTCT0272 and (01)00801741086328(17)200801(10)VTCV0384.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1432-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-03
Z-1432-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-03
Z-1433-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-03
Z-1434-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-03

Product code KNW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)