Z-0269-2016 Class II Terminated
FDA device recall Z-0269-2016 was initiated by Instrumentation Industries Inc on September 23, 2015 and is designated Class II. 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 manufactu… The recall status is terminated (terminated November 28, 2016). Affected quantity: 567.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- September 23, 2015
- Termination Date
- November 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 567
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
Distribution Pattern
Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
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