Surgical Convenience Kits Recalled by ROi CPS Due to Included 3M Surgical Drapes
ROi CPS LLC is recalling 456 surgical convenience kits containing 3M surgical drapes that were subject to a separate recall. The kits were distributed across 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 without reported illnesses or injuries. This is a precautionary recall of surgical kits distributed with a recalled component (3M surgical drapes), with no specific hazard detailed in the source.
Plain-English summary
ROi CPS LLC is recalling 456 units of ¿regard SHOULDER ARTHROSCOPY surgical convenience kits (Item Number 880044017, UDI/DI 10194717113478) because they were distributed containing 3M surgical drapes that were subject to a subsequent recall.
The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. Affected lot numbers are Lot 91163 (expiration 1/10/2024), Lot 91669 (expiration 2/25/2024), and Lot 92537 (expiration 5/15/2024).
The recalled product
- Product
- ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Affected units
- 456
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 (7)
- UDI/DI 10194717113478
- Lot Numbers: 91163
- exp 1/10/2024
- 91669
- exp 2/25/2024
- 92537
- exp 5/15/2024
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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