Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack
DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.
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: FDA Class II device recalls involve products with potential for serious adverse health consequences to users. Although no illnesses or injuries are reported and the specific hazard is not disclosed, the device classification itself indicates inherent risk of patient harm.
Plain-English summary
DeRoyal Industries Inc is recalling 68 kits of its CNRV Peripheral VAS Pack (Reference 89-10530.03). The affected lot numbers are: Lot 56618811 (exp 6/1/2023), Lot 56779017 (exp 1/1/2024), and Lot 57148495 (exp 2/1/2024).
The recall is voluntary and was initiated by the manufacturer on November 3, 2022. This is a Class II device recall. The specific reason for the recall is not disclosed in the FDA notice.
The recalled kits have been distributed to healthcare facilities in 23 US 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.
Healthcare facilities and consumers who have received these kits should check their lot numbers against those listed above. Contact DeRoyal Industries or your healthcare provider if you have questions about whether your product is affected.
The recalled product
- Product
- DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- device-defect
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 (3)
- Lot Numbers: Lot 56618811 exp 6/1/2023
- Lot 56779017 exp 1/1/2024
- Lot 57148495 exp 2/1/2024
Distribution
Distribution scope not specified by the agency.
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