Draeger Medical is recalling the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits after finding that glued connections may loosen before or during ventilation due to a manufacturing error.
Partial or complete detachment of components including the water trap, y-piece, or hose connector may occur as a result. Loosening or detachment of these parts can interrupt the breathing circuit and may cause severe injury including lack of oxygen or death. The risk of injury or death is especially great for critically ill patients including newborns.
The Draeger Medical Seattle-Positive Airway Pressure (PAP) Plus system is intended to provide bubble continuous positive airway pressure (CPAP) therapy that supports infants who are struggling to breathe while in the hospital.
The other products included in this recall are breathing circuit and/or anesthesia kits used together with ventilators during surgery or in the intensive care unit to support the breathing of infants, children, and adults.
Draeger Medical reports no injuries or deaths related to this issue.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The recalled products are:
- Product Names: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set (P) 110, ID Circuit Basic (P) 180, VentStar Anesthesia (N) 180, VentStar Basic (N) 180, VentStar Watertrap (N), 180 VentStar Bag Set (N) 110, VentStar Coax (P) 150, Anesthesia Circuit Kit Coax 1, Anesthesia Circuit Kit Coax 3, Ventstar Coax, Ventstar Coax 180, ID Coax 180, Ventstar Coax 230, Anesthesia Set Coax 180, Set2Go Ventilation 12 (A), and Anesthesia Circuit Kit Coax HEPA
- Product Material Numbers: See Recall Database Entry
- Distribution Dates: Jan 1, 2019, to Feb 28, 2023
- Devices Recalled in the US: 570,459
- Date Initiated by Firm: April 17, 2023
Who may be affected:
- Infants, children, and adults who receive breathing support from the Seattle PAP Plus or from ventilators that use the affected breathing circuit or anesthesia kits.
- Health care providers who provide care for patients with the Seattle PAP Plus or ventilators that use the affected breathing circuits or anesthesia kits.
What to do:
In April 2023, Draeger sent affected customers an Urgent Medical Device Recall letter with the following recommendations for breathing circuits shipped before March 20, 2023 that may be affected by this issue:
- Stop use of the affected products.
- Inspect current stock and quarantine/segregate any unused affected products to prevent their use.
- Institute alternative therapy as soon as possible. Alternative therapies may include: nasal continuous positive airway pressure (nCPAP), noninvasive positive pressure ventilation (NIPPV), high flow nasal canula, and invasive mechanical ventilation (last resort).
- Do not depend on any device output, for example, oxygen desaturation, to make decisions about whether to stop using the system.
- Ensure that all users of the products and others within the organization are made aware of the Urgent Medical Device Recall.
- Keep this information available to all users. Stop use of the affected products. Inspect current stock and quarantine/segregate any unused affected products to prevent their use.
- Customers with affected products should contact their local Draeger representative, who will provide information about alternatives.
- To replace/return unused products, contact Draeger Customer Success by phone between 8:00 AM – 6:00 PM EST Monday through Friday at 1-800-437-2437 (press 2 at the prompt, then 1) or via email at [email protected].
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.