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

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hem — recall Z-1776-2018

U.S. FDA — Device Enforcement · United States · 2018-02-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1776-2018
Date of alert: 2018-02-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Transonic Systems Inc
Product category: device
Product type: Devices

Reported risk: The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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