Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0269-2016 — Ventilator Tubing

U.S. FDA — Device Enforcement · United States · 2015-09-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0269-2016
Date of alert
2015-09-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Instrumentation Industries Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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