NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
- Company
- Draeger Medical, Inc.
- Recall Initiated
- January 23, 2023
- Posted
- February 24, 2023
- Recall Number
- Z-1138-2023
- Quantity
- 893 units
- Firm Location
- Telford, PA
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.
Distribution
US Nationwide Distribution
Lot / Code Info
All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)
Root Cause
Error in labeling
Action Taken
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