Ventilator Tubing
FDA Recall Z-0269-2016 · Posted None
Recalling FirmInstrumentation Industries Inc
Recall StatusTerminated
Product CodeBTO
Date Initiated2015-09-23
Date Terminated2016-11-28
Product Quantity567
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
Firm Action
Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consignees were asked to provide recall information to their customers. Customers with questions should call 412-854-1133, ext 433.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.