Surgical convenience kits recalled for containing 3M surgical drapes
ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.
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: FDA Class II medical device recall with no reported illnesses or injuries. The specific hazard associated with the included 3M surgical drapes is not disclosed in this notice, making the risk theoretical.
Plain-English summary
ROi CPS LLC is recalling regard BASIC NEURO, NU00259R surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
The recalled kits (Lot Number 91329, expiration date 11/27/2022) were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 190 units were affected.
The source recall notice does not specify the underlying hazard or defect associated with the 3M surgical drapes included in these kits.
The recalled product
- Product
- regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 190
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 10194717109914
- Lot Numbers: 91329
- exp 11/27/2022
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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