FDA Device recall Z-0269-2016
Ventilator Tubing
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Ventilator Tubing by Instrumentation Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0269-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-23 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumentation Industries |
| Distribution | CA, FL, GA, OH, PA, WA |
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
Identifiers
| code_info | Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515 KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0269-2016%22
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