Recall of Surgical Convenience Kits Containing Recalled 3M Drapes
ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
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 recall of surgical convenience kits with no reported hospitalizations, injuries, or illnesses. The specific hazard associated with the recalled drapes is not detailed in the source material.
Plain-English summary
ROi CPS LLC is recalling 258 surgical convenience kits (regard SPINE PACK, Item Number 800241010) distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subsequently recalled by their manufacturer.
The affected lot numbers are 92051 (expiration 7/1/2023) and 91671 (expiration 1/29/2024). The FDA has classified this as a Class II recall. The source notice does not specify the defect or hazard associated with the recalled drapes.
Affected healthcare facilities and patients should contact ROi CPS LLC or their healthcare provider for guidance on handling these kits.
The recalled product
- Product
- regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- 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 (5)
- UDI/DI 10194717110767
- Lot Numbers: 92051
- exp 7/1/2023
- 91671
- exp 1/29/2024
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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