FDA Recall Terminated

Ventilator Tubing

Recall: Z-0269-2016 · Initiated September 23, 2015

Recall

Recall Number
Z-0269-2016
Event Number
72396
Firm
Instrumentation Industries Inc
FEI Number
2518436
Product Code
BTO
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
September 23, 2015
Terminated
November 28, 2016
Address
2990 Industrial Blvd, Bethel Park, PA, 15102-2536

Description

Ventilator Tubing

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

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.

Distribution

Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.

Quantity

567