Z-0269-2016Class II

Ventilator Tubing

Name: Z-0269-2016 Ventilator Tubing
Creator: Instrumentation Industries Inc
Published: 2015-09-23
License: https://open.fda.gov/license/

Instrumentation Industries, Incorporated / initiated 2015-09-23 / Terminated / root cause: manufacturing process

FDA source

Instrumentation Industries Inc began a recall of Ventilator Tubing on 2015-09-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0269-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Posted: 2015-11-12
Terminated: 2016-11-28
Recalling firm: Instrumentation Industries, Incorporated
Product: Ventilator Tubing
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
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
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515 KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code BTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)