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

Recall Z-1447-2015 — Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is

U.S. FDA — Device Enforcement · United States · 2015-03-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1447-2015
Date of alert: 2015-03-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Peripheral Vascular Inc
Product category: device
Product type: Devices

Reported risk: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

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.

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