Recall Z-0269-2016— Instrumentation Industries Inc
Class II · Terminated
Class II FDA medical device recall by Instrumentation Industries Inc, initiated 2015-09-23, terminated 2016-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Ventilator Tubing. 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.
- Recalling firm
- Instrumentation Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-23
- Terminated
- 2016-11-28
- Firm location
- Bethel Park, PA, United States
Product description
Ventilator Tubing
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.