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EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single us...

FDA Device Recall #Z-2213-2019 — Class II — May 2, 2019

Recall Summary

Recall Number Z-2213-2019
Classification Class II — Moderate risk
Date Initiated May 2, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 125,292 units

Product Description

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Reason for Recall

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

Distribution Pattern

Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.

Lot / Code Information

Lot numbers VTCU0342, VTCU0343, VTCU0344, VTCU0345, VTCU0346, VTCU0347, VTCU0348, VTCU0349, VTCU0350, VTCV0372, VTCV0373, VTCV0374, VTCV0375, VTCV0376, VTCV0377, VTCV0378, VTCV0379, VTCV0380, VTCV0381, VTCV0382, VTCV0383, VTCW0448, VTCW0449, VTCW0450, VTCW0457, VTCW0458, VTCW0459, VTCW0460, VTCW0461, VTCW0462, VTCW0463, VTCW0464, VTCW0465, VTCW0466, VTCX0488, VTCX0489, VTCX0490, VTCX0491, VTCX0492, VTCX0493, VTCX0494, VTCX0495, VTCX0496, VTCX0497, VTCX0498, VTCX0499, VTCX0500, VTCX0501, VTCX0502, VTCY0551, VTCY0552, VTCY0553, VTCY0554, VTCY0555, VTCY0556, VTCY0557, VTCY0558, VTCY0559, VTCY0560, VTCY0562, VTCY0561, VTCY0563, VTCY0564, VTCY0565, VTCZ0650, VTCZ0651, VTCZ0652, VTCZ0653, VTCZ0654, VTCZ0655, VTCZ0656, VTCZ0657, VTCZ0658, and VTCZ0659.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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