NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving labeling clarification for proper storage conditions, with no reported injuries or adverse events. The issue is documentation-related, falling under cosmetic and documentation problems per the severity rubric.
Plain-English summary
The NeuRx Diaphragm Pacing System (NeuRx DPS), manufactured by Synapse Biomedical Inc, is a medical device system used for diaphragm pacing to assist breathing in patients with spinal cord injury or ALS.
The manufacturer has revised the device labeling to consistently identify and describe storage conditions. The instructions for use have been clarified to explicitly state that temperature range symbols on the device indicate storage conditions only, and do not refer to transport conditions or tolerance conditions for the package material. This clarification was necessary to prevent confusion about proper device storage.
This revision affects 71 units of the NeuRx DPS system and related components. Affected devices have been distributed domestically to healthcare facilities in Alabama, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, and West Virginia.
Patients and healthcare providers using affected units should review the updated device labeling and instructions for use to ensure the device is stored according to the specified temperature range.
The recalled product
- Product
- NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing S
- Manufacturer
- Synapse Biomedical Inc
- Hazard
- mis-labeling
Distribution
Distributed in 19 states:
- AL
- CA
- CO
- FL
- GA
- IL
- MA
- MI
- MN
- NC
- NJ
- NY
- OH
- OK
- OR
- PA
- SC
- TX
- WV
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