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U.S. Department of Health and Human Services

Class 1 Device Recall NovaStar TS SE (Standard Elbow), Reusable, NonInvasive Ventilation (NIV) Full Face Mask

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  Class 1 Device Recall NovaStar TS SE (Standard Elbow), Reusable, NonInvasive Ventilation (NIV) Full Face Mask see related information
Date Initiated by Firm January 23, 2023
Date Posted February 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-1138-2023
Recall Event ID 91538
510(K)Number K081743  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Code Information All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)
Recalling Firm/
Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
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 2
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 893 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