Surgical convenience kits containing recalled 3M surgical drapes
ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.
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 precautionary recall with no reported illnesses or injuries. The specific hazard associated with the recalled surgical drapes is not disclosed in this source, making it a routine protective measure rather than a response to identified patient harm.
Plain-English summary
ROi CPS LLC recalled their regard MAJOR CRANI surgical convenience kits because they contained 3M surgical drapes that were subsequently recalled. The specific reason for the 3M drape recall is not provided in this notice.
A total of 146 units of the kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. The affected kits carry UDI/DI 10174717110880 and include lot numbers 91522 (expires 2/7/2023), 91118 (expires 10/18/2023), 91705 (expires 12/30/2023), and 92034 (expires 1/26/2024).
No deaths or injuries have been reported related to this recall. Healthcare facilities and medical professionals in the affected states should stop using these kits and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 146
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 (9)
- UDI/DI 10174717110880
- Lot Numbers: 91522
- exp 2/7/2023
- 91118
- exp 10/18/2023
- 91705
- exp 12/30/2023
- 92034
- exp 1/26/2024
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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