Z-2213-2019Class II

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

Name: Z-2213-2019 EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx...
Creator: Bard Peripheral Vascular Inc
Published: 2019-05-02
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-05-02 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage... on 2019-05-02. FDA classified it as Class II and gives the reason as "There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2213-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-08-07
Terminated: 2022-03-03
Recalling firm: Bard Peripheral Vascular Inc
Product: 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.
Product code: KNW Instrument, Biopsy
Reason for recall: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
FDA root cause: Component change control
Action: The recalling firm issued letters dated 4/19/2019 via FedEx on 4/19/2019 with proof of delivery to the U.S. customers. The letters sent to foreign countries vary depending on the format required for the country.
Quantity in commerce: 125,292 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2213-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2210-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2211-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2212-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2213-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2214-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07

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)