DeRoyal Surgical Eye Spears Recalled for Incorrect X-Ray Detectability Labeling
DeRoyal Industries is recalling one lot of Surgical Eye Spears because they were labeled as x-ray detectable but contained non-detectable product.
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: The recall is classified as FDA Class II. The hazard involves a labeling error regarding x-ray detectability, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
DeRoyal Industries, Inc. is recalling one lot of DeRoyal Surgical Eye Spears, REF 30-049, Sterile EO. The recall involves 726 cases, containing a total of 7,242 units. The product is used for cleaning fluids from surgical sites in or near the eye.
The recall was initiated because the product was labeled as being x-ray detectable, but the actual product contained non-x-ray detectable material. This labeling discrepancy could affect the ability to detect the device via x-ray imaging if it were to be retained in a patient.
The affected product is identified by Lot Number 32794811. The items were distributed nationwide. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
- Manufacturer
- DeRoyal Industries Inc
- Hazard
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 Number 32794811
Distribution
Distributed nationwide across the United States.
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