Bunnell Patient Circuits Recalled Due to Heater Wire Insulation Melting

Plain-English summary

Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator. These circuits are required disposable components used to ventilate critically ill infants with specific pulmonary conditions. The recall covers 5,743 patient circuits distributed in the United States, Canada, Australia, Malaysia, and Uruguay.

Customer complaints indicate that the heater wire insulation in the circuit can melt. This melting can cause a short circuit, resulting in sparking and smoke near the humidifier cartridge. The affected lots were distributed between March 12, 2012, and November 30, 2012.

Healthcare facilities and users should stop using the affected Patient Circuits immediately. Bunnell, Inc. is the recalling firm and is responsible for managing the recall of these specific catalog numbers and lot numbers.

The recalled product

Product

Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circu

Manufacturer

Bunnell, Inc.

Category

Medical Device — Ventilator Component

Hazard

• fire
• smoke
• burn-injury

Affected units

5,743

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls