ROi CPS Recalls Isolation Droplet Bundle Kits Due to Labeling Error
ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits because the kits are labeled with an expiration date later than the expiration date of the soonest component.
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: The recall is classified as FDA Class II and involves a minor labeling error regarding expiration dates, which fits the criteria for a moderate severity recall.
Plain-English summary
ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits (Item: 830006013, Lot #: 78253M) due to a labeling error. The kits are labeled with an expiration date that is later than the expiration date of the soonest kit component to expire.
The affected kits were distributed domestically to Missouri and Louisiana. The recall is classified as Class II by the FDA.
Consumers should stop using the affected kits and contact ROi CPS LLC for further instructions.
The recalled product
- Product
- Isolation Droplet Bundle Kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Procedure Kits
- Hazard
- Affected units
- 24
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 (2)
- Item: 830006013
- Lot #: 78253M
Distribution
Part of a larger recall action
This product is one of 2 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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