Ventilator Tubing — Class II medical device recall Z-0269-2016
Terminated recall by Instrumentation Industries Inc, reported 2015-11-18, distributed in CA, FL, GA, OH, PA, WA. As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specif
| Recall number | Z-0269-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Industries Inc, Bethel Park, PA, United States |
| Recall initiated | 2015-09-23 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-11-28 |
| Distributed | CA, FL, GA, OH, PA, WA |
| Countries outside the US | CA |
| Quantity | 567 |
| Reason classes | packaging |
| Lot numbers | 036 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0269-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.