Medical Device Recall: DeRoyal HAND PACK Kit Lot 57685848
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall, which constitutes a risk-of-harm product per the severity rubric. With no illnesses or injuries reported and no specific hazard disclosed, the High severity reflects the regulatory classification indicating potential for serious adverse health consequences.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of the DeRoyal HAND PACK (REF 89-10314.03) on November 3, 2022. The recall involves 36 kits from lot number 57685848 (expiration date August 1, 2024). The specific reason for the recall has not been disclosed in available public documentation.
The affected kits were distributed to healthcare facilities in 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.
Facilities that received affected kits from this lot should contact DeRoyal Industries Inc for instructions. The FDA classified this as a Class II recall, which indicates potential for serious adverse health consequences. Healthcare providers should check lot number 57685848 on their products and discontinue use if applicable, then contact the manufacturer for replacement or further guidance.
The recall is ongoing as of the last FDA update.
The recalled product
- Product
- DeRoyal HAND PACK, REF 89-10314.03
- 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 57685848 exp 8/1/2024
Distribution
Distribution scope not specified by the agency.
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