Concerns about nickel exposure have prompted Percussionaire to recall nine lots of their Phasitron 5 breathing circuits. According to the FDA, this is a Class I recall due to risk of serious injury with use of the device.
The Phasitron 5 breathing circuit is part of an Intrapulmonary Percussive Ventilation (IPV) system used with patients receiving ventilation support. Percussionaire announced a recall of the breathing circuits after three reports of injury linked to use of the device. An investigation determined that the mixture of saline and albuterol typically used with the IPV system can react with the nickel coating in the breathing circuit. When this happens, the nickel can become “aerosolized,” which can then expose patients undergoing ventilation therapy to dangerous levels of the metal. Possible risks of such an exposure include allergic reaction, pulmonary injury, constriction of the airways, decreased immunity, and in the most serious cases, death.
Percussionaire is recalling the following lot numbers of the Phasitron 5 breathing circuits: P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625; P5-HC-5/240321; P5-UC-10/240627. The company asks health care facilities and users to dispose of any products from the affected lots that have already been used or opened. Customers should return all unopened and unused products to the company. Additionally, customers and health care providers should return the acknowledgement form included with Percussionaire’s Urgent Medical Device Recall letter.
For those who do not have access to a replacement device and who have no choice but to continue use of the Phasitron 5 breathing circuits, the company advises cleaning the device with sterile water after each use. Users should only use saline with the device and should not use the Phasitron 5 breathing circuits to deliver medications (e.g. albuterol). Furthermore, use of the device should not exceed two weeks and should be stopped immediately in the event of adverse symptoms.
Anyone with questions or concerns about the recall can contact FSCA@sentec.com.
Patients and health care providers can report any new adverse health events related to Percussionaire’s Phasitron 5 breathing circuits through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of Phasitron 5 breathing circuits, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.