Z-0351-2012

The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver...

Name: Z-0351-2012 The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver...
Creator: Bard Peripheral Vascular Inc
Published: 2011-11-03
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2011-11-03 / Terminated / root cause: packaging

FDA source

Bard Peripheral Vascular Inc began a recall of The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use... on 2011-11-03. The reason FDA records is "This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0351-2012
Status: Terminated
Initiated: 2011-11-03
Posted: 2011-12-02
Terminated: 2012-03-29
Recalling firm: Bard Peripheral Vascular Inc
Product: The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.
Product code: FCK Instrument, Biopsy, Suction
Reason for recall: This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm sent the customer notification letter on 11/07/11, via FedEx with proof of delivery notice. The letter notified customers of the reason for recall that units from the affected lot may have packaging damage resulting from transportation. The letter instructed customers to check all inventory locations , remove any identified product, to not use the affected product, and return the affected product to Bard Peripheral Vascular, Inc., 1415 W. 3rd Street, Tempe, Arizona 85281. The letter also instructed customers to fill out the recall and effectiveness check form and fax it to 1-800-894-6772. Customers were instructed to call 1-800-321-4254, Option #2 Ext 2727 for a return authorization number to facilitate the expedient return of the product. For questions regarding this recall call 480-894-9515
Quantity in commerce: 64570 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia
Product codes and lots: ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G.

Product code FCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)