Eye Surgery Kit Recall Due to Defective Surgical Drapes
ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.
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: This is an FDA Class II recall with no reported illnesses or injuries. The source does not specify the nature of the defect in the surgical drapes. Per the rubric, Class II recalls without reported harm or hospitalization are scored 2 (Moderate).
Plain-English summary
ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits (Model EY00450K, Item Number 880295011) that were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that have been recalled.
The recall affects surgical convenience kits containing defective 3M surgical drapes. Facilities that received these kits should immediately discontinue use.
Affected facilities should contact ROi CPS LLC for instructions on returning the recalled kits. The affected lot number is 91479, with an expiration date of February 10, 2024.
This is an FDA Class II recall (Z-0315-2023). For additional information, consult the FDA's CDRH recall database.
The recalled product
- Product
- regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Affected units
- 738
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)
- UDI/DI 10194717104643
- Lot Numbers: 91479
- exp 2/10/2024
Distribution
Part of a larger recall action
This product is one of 40 recalled by ROi CPS LLC 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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