Voluntary Recall of DeRoyal Biopsy Pack Medical Device Kits
DeRoyal Industries initiated a voluntary recall of 560 biopsy pack kits (lot 56094211) distributed across multiple US states. The specific reason for the recall was not documented in the available source.
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 a Class II FDA device recall initiated voluntarily by the manufacturer. No illnesses, injuries, or fatalities are reported in the source documentation, and the specific hazard or reason for recall is not documented. Voluntary recalls without identified adverse events or stated risk details are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc is recalling 560 units of the DeRoyal BIOPSY PACK (REF 89-9270.04), lot 56094211, with an expiration date of May 1, 2024. This is a voluntary, manufacturer-initiated recall classified as FDA Class II.
The affected biopsy pack kits were distributed across the United States, including 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 recall was initiated on November 3, 2022, and was ongoing as of the report date of December 21, 2022.
The source documentation does not specify the reason for this recall. Healthcare facilities and medical professionals who received biopsy packs from this lot should contact DeRoyal Industries Inc for further guidance and instructions regarding the affected inventory.
The recalled product
- Product
- DeRoyal BIOPSY PACK, REF 89-9270.04
- Manufacturer
- DeRoyal Industries Inc
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 56094211 exp 5/1/2024
Distribution
Distribution scope not specified by the agency.
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