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NovaStar TS, Standard elbow, Reusable, Material Numbers… recallZ-1138-2023 · Draeger Medical, Inc. · initiated Jan 23, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-1138-2023
Status
Open, Classified
Initiated by the company
Jan 23, 2023
Posted by the FDA
Feb 24, 2023
Recalling firm
Draeger Medical, Inc.
Quantity
893 units
Product code
CBK
FDA submissions
K081743
Distribution
US Nationwide Distribution

Product description

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Code information (models, lots, serial numbers)

All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K081743 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91538).

Sources and updates

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