Surgical Convenience Kits Containing Recalled 3M Surgical Drapes
Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.
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 convenience kits are being recalled on a precautionary basis because they contain 3M surgical drapes that were subject to a separate recall.
Plain-English summary
The ¿regard EYE TRAY surgical convenience kits (Item Number 880099031) manufactured by ROi CPS LLC are being recalled because they contain 3M surgical drapes that were subject to a separate recall.
A total of 258 kits are affected. These products were distributed in Louisiana, Missouri, North Carolina, and Florida. Affected units are identified by lot numbers 92643 (expiration 5/24/2024), 93393 (expiration 8/18/2024), and 93669 (expiration 9/26/2024), and can be confirmed using UDI/DI 10194717113485.
Hospitals, surgical centers, and other facilities with affected kits should not use them. Contact ROi CPS LLC for further instructions regarding return, replacement, or disposal of recalled products.
The recalled product
- Product
- ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 258
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 (7)
- UDI/DI 10194717113485
- Lot Numbers: 92643
- exp 5/24/2024
- 93393
- exp 8/18/2024
- 93669
- exp 9/26/2024
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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