Medical device recall issued for DeRoyal CRANI PACK across multiple states
DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.
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: FDA Class II medical device recall with no reported illnesses or injuries. The specific hazard was not disclosed in available source documentation, limiting assessment of additional severity factors.
Plain-English summary
DeRoyal Industries Inc has voluntarily recalled the DeRoyal CRANI PACK (Model REF 89-10242.02) distributed across multiple 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 recall involves 6 kits with Lot Number 56388307 (expiration date August 1, 2023). The manufacturer initiated the recall on November 3, 2022, and the status remains ongoing. The specific hazard, reason for recall, or nature of the defect was not provided in the agency documentation.
No illnesses or injuries have been reported. Facilities or individuals with affected units should contact DeRoyal Industries for information regarding return, replacement, or disposal instructions.
The recalled product
- Product
- DeRoyal CRANI PACK, REF 89-10242.02
- 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 56388307 exp 8/1/2023
Distribution
Distribution scope not specified by the agency.
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