Draeger issues recall notification to address potential health risks related to possible separation of breathing hose components in certain breathing circuits

Telford, PA, April 18, 2023 (GLOBE NEWSWIRE) -- Draeger, Inc., a subsidiary of Draegerwerk AG & Co. KGaA, is initiating a voluntary recall notification for Draeger Coax Ventilation Hoses, Draeger Neo Disposable Breathing Systems, Draeger Pediatric Disposable Breathing Systems, Draeger Seattle PAP plus, and Draeger Set2Go to address the potential risk that glued connections of the breathing circuits may loosen either before or during the ventilation process, which could result in partial or complete detachment of components such as the water trap, y-piece or hose connector. To date, there are no reports of any adverse impacts on the health of patients in connection with this potential risk.

Draeger immediately stopped shipment of affected products once these potential risks were identified. Draeger has since implemented changes to the gluing process used during manufacturing to help address these potential risks. Testing of the updated gluing process has been completed for Seattle PAP (MP02260), and Draeger started distributing Seattle PAP product utilizing this updated gluing process to customers as of March 20, 2023. Testing is still ongoing for the remaining circuits, and all impacted customers have been offered an alternative product as a temporary replacement. 

Only the products listed below (all lot numbers) are affected:

* Lot Number 0367.2702.13 Not Affected (Distributed after March 20, 2023)

Potential Patient Impact

If system components become loose and/or detach from the hose during use, ventilation of the patient will be restricted.

For Seattle PAP plus (shipped prior to March 20, 2023:                                                                                                           

A detachment of system components may cause desaturation of the patient/hypoxia due to a loss of airway pressure caused by a leak. Patient monitoring (such as SpO₂) is designed to detect desaturation of the patient.

For Draeger Neo and Draeger Pediatric disposable breathing systems:

A detachment of system components may cause hypoxia due to a loss of airway pressure caused by a leak. If the breathing systems are used with devices that are listed in the instructions for use (IFU) as being compatible, the devices are designed to detect and give an alarm with respect to such leakage.  

For Draeger Coax ventilation hoses:

A detachment of system components may also cause hypoxia due to either:

• A leak of the outer hose, leading to a loss of airway pressure, or
• A leak of the inner hose, leading to rebreathing of exhaled gas, or
• Torsion of the inner hose, leading to an obstruction.

If Draeger Coax ventilation hoses are used with devices that are listed in the IFU as being compatible, a leakage and/or an obstruction will be detected, and the device will give an alarm.  

Required Action

If you have received breathing circuits that were shipped prior to March 20, 2023 that may be affected by this issue, please follow the below instructions:

• Stop use of the affected products. Inspect current stock and quarantine/segregate any unused affected products to prevent their use.
• Alternative therapy should be instituted as soon as possible. These 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 (e.g., oxygen desaturation) to make decisions regarding whether to stop using the system. 
• Please ensure that all users of the above-mentioned products and other persons within your organization are made aware of this Urgent Medical Device Recall.
• Please keep this information available to all users at least until you have checked your stock and quarantined/segregated any unused affected products to prevent their use.

If you have affected products in your inventory, please contact your local Draeger consumables representative, who will be able to provide you with information regarding alternative products. 

To replace/return unused products, please contact Draeger Customer Success via phone between the hours of 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 US-Medical@draeger.com. You will also be provided with a Return Material Authorization and pre-paid shipping documents to return the unused product to Draeger. 

If you have any questions, you may contact Michael Kelhart between the hours of 8:00 AM – 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com. 

Adverse reactions or quality problems experienced with the use of these products may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: Complete and submit the report online
• Regular mail or fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Affected customers have been notified. This voluntary medical device recall has been reported to the FDA. 

Draeger. Technology for Life^®

Draeger is an international leader in the fields of medical and safety technology. Our products protect, support, and save lives. Founded in 1889, Draeger generated revenues of around EUR 3 billion in 2022. The Draeger Group is currently present in over 190 countries and has more than 16,000 employees worldwide. Please visit www.draeger.com for more information.