Instrumentation Industries Inc: Medical Device Recall in 2015 - (Recall #: Z-0269-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Ventilator Tubing

Product Classification:

Class II

Date Initiated: September 23, 2015

Date Posted: November 18, 2015

Recall Number: Z-0269-2016

Event ID: 72396

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

Status: Terminated

Product Quantity: 567

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated