Instrumentation Industries Inc recalls Ventilator Tubing

Recall date

September 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0269-2016

FDA classification

Class II

Brand / firm

Instrumentation Industries Inc

Sold / distributed

Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ventilator Tubing