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Recall Observatory FDA recall evidence

Device product

Ventilator Tubing

Z-0269-2016

September 23, 2015

Class II

Product summary

Firm
Instrumentation Industries Inc
Event
Event 72396
Status
Terminated
Classification
Class II
Quantity
567
Official record key
device-enforcement:Z-0269-2016

Official wording

Reason: 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

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

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect