FDA-Device2015-11-18Class II

Ventilator Tubing

Instrumentation Industries Inc
Hazard

As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage

Sold states
Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
Affected count
567
Manufactured in
2990 Industrial Blvd, N/A, Bethel Park, PA, United States
Products
Ventilator Tubing

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2016

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