Class 2 Device Recall KC 036, KC 060, KC 072 Cuffed Ventilator Tubing

• Date Initiated by Firm: September 23, 2015
• Create Date: November 12, 2015
• Recall Status: Terminated on November 28, 2016
• Recall Number: Z-0269-2016
• Recall Event ID: 72396
• Product Classification: Tube, tracheostomy (w/wo connector) - Product Code BTO
• Product: Ventilator Tubing
• Code Information: Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515 KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515
• Recalling Firm/ Manufacturer: Instrumentation Industries Inc; 2990 Industrial Blvd; Bethel Park PA 15102-2536
• For Additional Information Contact: 412-854-1133
• Manufacturer 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
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 567
• Distribution: Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.