Recall Z-1138-2023 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
| Date | Feb 24, 2023 (initiated Jan 23, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 893 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS Draeger Medical AG & Co. KG, Sep 22, 2008 |