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U.S. Department of Health and Human Services

Class 2 Device Recall The EnCor biopsy probe

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  Class 2 Device Recall The EnCor biopsy probe see related information
Date Initiated by Firm November 03, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-0351-2012
Recall Event ID 60347
Product Classification Instrument, biopsy, suction - Product Code FCK
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.
Code Information ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G.
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact
480-894-9515
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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