DeRoyal Endovascular Tracepack Medical Device Recall, FDA Class II
DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
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 Class II medical device recall with no reported illnesses, injuries, or disclosed hazard reason in available FDA documentation. Meets the criteria for Moderate severity as a firm-initiated voluntary precautionary recall.
Plain-English summary
DeRoyal Industries Inc initiated a recall of its ENDOVASCULAR TRACEPACK, reference number 89-9350.03, involving approximately 495 kits. The recall affects multiple lot numbers with expiration dates ranging from June 2024 to January 2025, distributed across 23 U.S. states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, and others.
The U.S. Food and Drug Administration classified this as a Class II recall, indicating a potentially significant device issue. However, the specific reason for the recall has not been publicly disclosed in the FDA documentation available.
Healthcare facilities that received the affected product should verify whether they have stock of any of the following lot numbers: 56225516, 56395460, 56620751, 56780958, 57190141, or 57754751. Facilities with affected kits should contact DeRoyal Industries Inc for further guidance regarding product management, return, or replacement. The recall remains ongoing as of the date of this notice.
The recalled product
- Product
- DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
- 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 (6)
- Lot Numbers: Lot 56225516 exp 6/1/2024
- Lot 56395460 exp 6/1/2024
- Lot 56620751 exp 10/1/2024
- Lot 56780958 exp 10/1/2024
- Lot 57190141 exp 10/1/2024
- Lot 57754751 exp 1/1/2025
Distribution
Distribution scope not specified by the agency.
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