Medical device NEURO PACK subject to nationwide voluntary recall
DeRoyal Industries has issued a voluntary recall of 45 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed by the manufacturer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Voluntary recall of a Class II medical device with no reported adverse events or disclosed hazard. The source lists only a placeholder reason (XXX), consistent with a precautionary firm-initiated recall.
Plain-English summary
DeRoyal Industries Inc is recalling 45 kits of the NEURO PACK medical device (Reference 89-9253.09, Lot 57760211, expiration 3/1/2025). This Class II device recall was initiated voluntarily by the manufacturer on November 3, 2022. The specific reason for the recall was not disclosed in the available source documentation.
The recalled kits were distributed to healthcare facilities across 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi. The manufacturer notified affected recipients through multiple channels including email, fax, letter, press release, telephone, and in-person facility visits.
Healthcare providers and medical facilities in the affected states that received this product should contact DeRoyal Industries Inc to determine whether they have received recalled units and for guidance on appropriate next steps. As of the most recent report date in December 2022, the recall status remains ongoing.
The recalled product
- Product
- DeRoyal NEURO PACK, REF 89-9253.09
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: Lot 57760211 exp 3/1/2025
Distribution
Distribution scope not specified by the agency.
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