Class 1 Device Recall NovaStar TS AAV (Antiasphyxia Valve), Reusable, NonInvasive Ventilation (NIV) Full Face Mask

• Date Initiated by Firm: January 23, 2023
• Date Posted: February 24, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1137-2023
• Recall Event ID: 91538
• 510(K)Number: K081743
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
• Code Information: All Lot numbers. UDI-DI: 04048675041146 (MP10576); 04048675041153 (MP01577); 04048675041160 (MP01578)
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Michael A. Kelhart; 215-721-5400
• Manufacturer Reason for Recall: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
• FDA Determined Cause: Error in labeling
• Action: An Urgent Medical Device Correction notification letter dated January 2023 was sent to customers. Actions to be taken: Use of the mask is contraindicated for patients and other persons in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to: ¿ Pacemakers ¿ Implantable cardioverter defibrillators (ICD) ¿ Neurostimulators ¿ Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head) ¿ Cerebral spinal fluid (CSF) shunts (e.g., ventriculoperitoneal (VP) shunt) ¿ Aneurysm clips ¿ Embolic coils ¿ Intracranial aneurysm intravascular flow disruption devices ¿ Metallic cranial plates, screws, burr hole covers, and bone substitute devices ¿ Metallic splinters in the eye ¿ Ocular implants (e.g., glaucoma implants, retinal implants) ¿ Certain contact lenses with metal ¿ Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants) ¿ Magnetic denture attachments ¿ Metallic gastrointestinal clips ¿ Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary) ¿ Implantable ports and pumps (e.g., insulin pumps) ¿ Hypoglossal nerve stimulators ¿ Devices labeled as MR (Magnetic Resonance) unsafe ¿ Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field Apart from the contraindication, you can continue to use NovaStar masks, if you ensure that the magnets are kept at least 15 cm (approx. 6 inches) away from any other medical implants or medical devices that can be impacted by the magnetic fields. According to our records, your facility has received NovaStar TS masks material number MP01576, MP01577, MP01578, MP01579, MP01580, and/or MP01581, manufactured by Draegerwerk AG & Co. KGaA. Please add a copy of this Urgent Medical Device Correction Notification to every box of masks you have in your facilit
• Quantity in Commerce: 16 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = DRAEGER MEDICAL AG & CO. KG