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

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a — recall Z-1899-2012

U.S. FDA — Device Enforcement · United States · 2012-05-29 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1899-2012
Date of alert
2012-05-29
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Carefusion 2200 Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0000414257
Reported risk: The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.