Medical device recall: DeRoyal Retinal Pack kits
DeRoyal Industries recalled 64 DeRoyal Retinal Pack kits (Lot 57000221, Lot 57413324) distributed across 23 U.S. states. The specific reason for the recall was not disclosed.
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 2/5 (Moderate).
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 classification with no reported illnesses, injuries, or deaths. This is a voluntary, firm-initiated precautionary recall with no evidence of patient harm.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 64 DeRoyal Retinal Pack kits (model REF 89-7336.07). The recalled kits are identified by Lot 57000221 (expires 9/1/2024) and Lot 57413324 (expires 12/1/2024).
The specific reason for the recall was not publicly disclosed by the FDA or the manufacturer at the time of recall initiation.
The affected kits were distributed to healthcare facilities across 23 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 was initiated on November 3, 2022, and remains ongoing.
No illnesses or injuries related to these products have been reported. Healthcare providers in possession of the affected lot numbers should refer to communications from DeRoyal Industries regarding proper handling and disposition of the recalled kits.
The recalled product
- Product
- DeRoyal RETINAL PACK, REF 89-7336.07
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 64
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 (2)
- Lot Numbers: Lot 57000221 exp 9/1/2024
- Lot 57413324 exp 12/1/2024
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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