Class II — Instrumentation Industries Inc
| Recalling firm | INSTRUMENTATION INDUSTRIES, INCORPORATED |
|---|---|
| Registered facility | INSTRUMENTATION INDUSTRIES, INCORPORATED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | Ventilator Tubing |
| Quantity | 567 |
| Distribution | Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada. |
| Initiated | 2015-09-23 |
| Classified | 2015-11-12 |
| Terminated | 2016-11-28 |
| Recall number | Z-0269-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Instrumentation Industries Inc (Z-0269-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72396/
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