Device product
Ventilator Tubing
Z-0269-2016
Product summary
- 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
manufacturing defect