FDA Class II recall: DeRoyal surgical procedure pack distributed to multiple states
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall, which by definition indicates a risk-of-harm product with potential for serious adverse health consequences. No incidents, injuries, or illnesses have been reported in connection with the recall.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of the DeRoyal OPEN SHOULDER PROCEDURE PACK RF (REF 89-6629.07) beginning November 3, 2022. The recall involves 3 kits with Lot Number 56391733 (expiration 3/1/2024) distributed to medical facilities 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 specific defect or reason for this FDA Class II recall is not provided in the available information. Healthcare facilities in the affected states should contact DeRoyal Industries Inc directly for details about the recall and any recommended actions. The recall status is listed as ongoing.
The recalled product
- Product
- DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 3
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 56391733 exp 3/1/2024
Distribution
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.
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