Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2214-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

U.S. FDA — Device Enforcement · United States · 2019-05-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2214-2019
Date of alert: 2019-05-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Peripheral Vascular Inc
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2214-2019 — EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

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