DeRoyal PORT PACK medical device recalled: lot-specific kits
DeRoyal Industries Inc is voluntarily recalling 240 kits of the PORT PACK PGYBK medical device distributed across 22 U.S. states. The specific reason for recall is not disclosed in available source material.
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: This is an FDA Class II device recall with no reported illnesses or injuries and an undisclosed hazard. The recall is voluntary, and the absence of disclosed harm or known defect details warrants Moderate severity.
Plain-English summary
DeRoyal Industries Inc, based in Powell, Tennessee, has voluntarily initiated a recall of 240 kits of the DeRoyal PORT PACK PGYBK (REF 89-8748.05). The recall affects two specific lot numbers: Lot 56250480 (expiring 9/1/2024) and Lot 57391954 (expiring 10/1/2024).
The product was distributed to healthcare facilities in 22 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, and Georgia.
The FDA classified this as a Class II device recall. No illnesses or injuries have been reported in the source material. The specific hazard or reason for the recall is not disclosed in this notice.
The recall was initiated on November 3, 2022, and remains ongoing. Healthcare facilities that received affected kits should contact DeRoyal Industries Inc for guidance on handling or return of the product.
The recalled product
- Product
- DeRoyal PORT PACK PGYBK, REF 89-8748.05
- 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 (2)
- Lot Numbers: Lot 56250480 exp 9/1/2024
- Lot 57391954 exp 10/1/2024
Distribution
Distribution scope not specified by the agency.
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