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

Recall Z-1527-2013 — BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. P

U.S. FDA — Device Enforcement · United States · 2013-01-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1527-2013
Date of alert: 2013-01-23
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 (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

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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