NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

FDA device recall Z-1137-2023 · posted 2023-02-24 · Open, Classified

Recall details

Recalling firm

Draeger Medical, Inc.

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.

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

Root cause

Error in labeling

Status

Open, Classified

Product code

CBK

Quantity affected

16 units

Distribution

US Nationwide Distribution

Date initiated

2023-01-23

Date posted

2023-02-24

Location

Telford, PA

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