Surgical Convenience Kits Recalled Due to Defective Component Drapes
ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.
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 injuries or illnesses. The kits are being removed due to containing surgical drapes subject to a separate recall. This is a precautionary recall with no indication of clinical harm.
Plain-English summary
ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits (Item Number 880179014) used in neurosurgery. The kits contain 3M surgical drapes that were subject to a subsequent FDA recall. The kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
The affected lot numbers are: 92239 (expiration 11/27/2023) and 91440 (expiration 12/7/2023). The universal device identifier (UDI/DI) is 10194717109457.
Healthcare facilities that received these kits should stop using them immediately and contact ROi CPS LLC. Check your inventory against the lot numbers and UDI provided. Do not use any kits with the affected lot numbers.
The recalled product
- Product
- regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 188
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 10194717109457
- Lot Numbers: 92239
- exp 11/27/2023
- 91440
- exp 12/7/2023
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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