The Recall Desk
ModerateFDA (Devices)·Z-0654-2023·Announced 2022-12-21

DeRoyal EMERGENT TRAUMA PACK recall affects 18 kits across 23 states

DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.

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: Classified as FDA Class II, but the specific hazard is not documented in the source material. No illnesses or injuries are reported. Without articulation of the specific risk, a Moderate rating reflects the incomplete hazard information available.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling 18 units of the EMERGENT TRAUMA PACK, REF 89-9453.14. The recall involves Lot Number 57754971 (expiration date 1/1/2025) and affects distribution across 23 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 detailed reason for this recall is not specified in the available FDA documentation. This is an ongoing, voluntary recall initiated by the manufacturer on November 3, 2022, and classified as FDA Class II.

Healthcare facilities and individuals who may have received this product should contact DeRoyal Industries Inc for guidance on this recall and any necessary actions regarding the affected units.

The recalled product

Product
DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Emergency/Trauma Supplies
Affected units
18

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 57754971 exp 1/1/2025

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

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