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

FDA device recall Z-0351-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

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

Root cause

Packaging

Status

Terminated

Product code

FCK

Quantity affected

64570 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia

Date initiated

2011-11-03

Date posted

2011-12-02

Date terminated

2012-03-29

Location

Tempe, AZ