Surgical convenience kits recalled due to included 3M surgical drapes
Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities 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 with no reported illnesses, injuries, or deaths. This is a precautionary recall addressing kits containing previously-recalled surgical drapes; the specific hazard is not detailed in the source text.
Plain-English summary
ROi CPS LLC is recalling surgical convenience kits (regard SPINE PACK, model NU00260H) that contain 3M surgical drapes which were previously recalled. A total of 164 units were distributed to surgical facilities in Louisiana, Missouri, North Carolina, and Florida.
The source text does not specify what defect or issue prompted the original 3M surgical drape recall, only that the drapes were subsequently recalled. Because these drapes were included in the surgical convenience kits, the kits are being recalled as a secondary consequence. This is an FDA Class II recall.
The recalled product
- Product
- regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 164
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 10194717108849
- Lot Numbers: 91281
- exp 5/28/2023
- 91103
- exp 10/11/2023
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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