Eye Surgery Convenience Kits Recalled for Defective Surgical Drapes
Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.
What this means for you
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, injuries, or deaths in the source material. The specific hazard related to the recalled surgical drapes is not identified in the source text.
Plain-English summary
ROi CPS LLC is recalling 780 regard CATARACT eye surgery convenience kits (Item Number 880295012, UDI/DI 10194717114635, Lot Number 92164, expiration date April 7, 2024) that were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The surgical convenience kits contain 3M surgical drapes which were subsequently recalled.
Facilities that received these kits should contact ROi CPS LLC or the FDA for information on how to proceed with the affected products.
The recalled product
- Product
- regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 780
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 10194717114635
- Lot Numbers: 92164
- exp 4/7/2024
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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