Medical Device recall

Be advised that the RHCAA acknowledges that the information provided below is publicly accessible, and this statement is only intended as a courtesy to the RHCAA members. Please be aware that the information below could change at any time. Accordingly, while the RHCAA has made every effort to ensure the completeness and accuracy of the information, the RHCAA members, as Service Providers of the product in question, are ultimately responsible to provide proper information tailored to the distinct needs of each of their clientele. Each Service Provider must use the below information at its own discretion.

On June 14, 2021, Respironics Ltd. released a Field Safety Notification announcing a voluntary recall of its Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators due to associated health risks. Health Canada since issued a Recall on June 23, 2021, listing 35 affected products by name. The full list of affect products and Health Canada’s reasons for the Recall can be found here.

According to the manufacturer’s Field Safety Notification and according to the Health Canada Recall, the polyester-based polyurethane foam used for sound abatement in the listed devices may degrade due to high heat and humidity. The degraded foam may turn into particles and it may also emit certain chemicals. Be aware that unapproved cleaning methods may accelerate the foam degradation.

In the Field Safety Notification, the manufacturer warned that there are potential health risks associated with exposure to those particles and chemicals. The manufacturer listed the following as potential safety hazards associated with use: irritation to skin, eyes, and respiratory tract, inflammatory response, headache, asthma, adverse effects on organs, and toxic carcinogenic affects. Further information on the potential health risks can be found here.

The manufacturer has created a registration process for patients to look up their device serial number and begin a claim if that device is deemed affected. Alternatively, a Consumer may call 1-877-907-7508 for the same registration process.

The RHCAA acknowledges that the Field Safety Notification recommends Consumers take the following actions:

1. For patients using life-sustaining mechanical ventilator devices, do not stop or alter your prescribed therapy until you have spoken with your physician.

2. For patients using BiLevel PAP and CPAP devices, discontinue use of your device and consult your physician or Durable Medical Equipment provider to determine the most appropriate option for continued treatment.

In light of these recommendations, the RHCAA stresses the importance that Consumers directly consult with their physicians to obtain individual medical advice regarding their use of an affected device. Upon seeking individual medical information from a physician, the patient may then be better able to weigh the risks of continuing use against the risks of discontinuing use.

The RHCAA is unaware of the anticipated timeframe for the repair or replacement of these devices and is awaiting further guidance from the manufacturer. The RHCAA acknowledges the urgency to provide replacement devices for patients; however, the RHCAA does not control the supply of replacement devices. Thus, the RHCAA is unable to facilitate the expedient replacement of the affected devices. Nevertheless, the RHCAA is zealously advocating for the health and safety of its members as well as its members’ patients and customers. The RHCAA is also making all efforts to support its members at this time.

Upon receiving new information relating to the Recall of the affected devices, the RHCAA endeavors to provide that information to its membership and their patients as soon as practicable.