FDA Alerts, CDC Updates, And Other Important Public Notices for Pediatric Patients and Families
Here at Wave Healthcare, it is always a priority to keep our patients and their families informed. This means we make a point to share notifications from The U.S. Food and Drug Administration (FDA) that may have an impact on the care and equipment we provide. FDA alerts, CDC updates, and other public notices for pediatric patients and families requiring children’s respiratory and nutritional healthcare can be found on this page. Alerts may include, but are not limited to, national product shortage notifications, equipment recalls, and updates to recommended care procedures and product guidelines.
NOTICE: The US FDA alert regarding Possible Environmental Contamination of Device Sensor for Trilogy Evo, Trilogy Evo 02, Trilogy Evo Universal, Trilogy EV300
A problem has been identified with the Philips Respironics Trilogy Evo 02, Trilogy Evo Universal, Trilogy EV300, and Trilogy Evo ventilators that could pose a risk for patients if not mitigated. Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A…
NOTICE: The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes-agency recommendations for users are available here.
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be…
NOTICE: PediaSure Harvest Recall
Lyons Magnus, a third-party manufacturer for Abbott, is expanding its voluntary recall initiated on July 28, 2022 to include Ensure Harvest, PediaSure Harvest and additional lots of ClubPack Glucerna Original Vanilla, Chocolate, and Strawberry in 8 fluid oz cartons. NOTE: Of those products, the ONLY product currently being used by Wave Healthcare patients is the…
NOTICE: Information from the CDC regarding Monkeypox
Wave Healthcare would like to assure our patients and their families that we are closely following the CDC’s ongoing reports and recommendations regarding the recent Monkeypox outbreak. We have formed a task committee that is committed to keeping our staff and clinical team educated and up to date so that we may ensure the safety…
NOTICE: Kate Farms-Expanded Voluntary Recall
Wave Healthcare has received notification that the Lyons Magnus voluntary recall of Kate Farms Pediatric Standard 1.2 Vanilla now includes additional Kate Farms products. The following link provides all information needed to find out if you have a product that has been impacted by the recall https://myproductinformation.com/product-information/ Additionally, support is available from the Kate Farms…
NOTICE: New Guidelines Encourage Transition to ENFit Enteral Connectors
7/26/2022 Wave Healthcare would like to inform our families of the new guidelines from the Global Enterprise Device Supplies Association (GEDSA) regarding feeding tubes and supplies. In an effort to improve patient safety and guard against accidental medical tubing misconnections, the International Organization for Standardization (ISO) developed the ISO 80369-3 enteral connector standard. The new…
NOTICE: Updates Regarding Formula Recall and Backorders
The information below includes details about how qualifying families can obtain one case of free Abbott Elecare infant or Elecare Jr. formula. Also included is a letter provided to Wave Healthcare by formula manufacturing company Mead Johnson regarding the latest on specific information about product availability including PurAmino Junior, Nutramigen Toddler, and Pregestimil. Wave Healthcare…
NOTICE: Important Information on Bivona Tracheostomy Tube Supply
The following letter was provided to Wave Healthcare by Smith Medical. Wave Healthcare is committed to providing you with information about the current supply chain situation and will continue to share the most up-to-date information as it is received. For questions, please reach out to your respiratory therapist or contact us at 866-935-9283 (WAVE). 17th…
NOTICE: Important Information on Bacteria Filters and Most Recent Remediation Updates for Philips Trilogy 100/200
We understand the impact that the Philips recall notification on certain products has had on our patients. Patient safety is our top priority, and we want to make sure as many patients as possible can continue with their therapy. In circumstances where a physician determines that a patient should continue the use of the affected…