FDAClass IINovember 18, 2015

Ventilator Tubing recall

Ventilator Tubing

Why was Ventilator Tubing 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515 KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515

Product
Ventilator Tubing
Recalling firm
Instrumentation Industries Inc
Quantity
567
Distribution
Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
Recall date
November 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls