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

Recall Z-0815-2014 — Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted P

U.S. FDA — Device Enforcement · United States · 2013-12-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0815-2014
Date of alert: 2013-12-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Access Systems
Product category: device
Product type: Devices

Reported risk: Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.

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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