ROi CPS LLC Recalls Regard Dressing Change Trays Due to Microbial Growth
ROi CPS LLC is recalling 272 Regard Dressing Change Trays because ChloraPrep applicators in the kits can grow organisms that breach package integrity.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ROi CPS LLC is recalling 272 units of the Regard Dressing Change Tray. The recall was initiated because ChloraPrep applicators included in the kits can grow organisms that result in a breach of the applicators' package integrity.
The affected products were distributed nationwide in the state of Louisiana. The specific lot numbers involved in this recall are 86983C, 87081C, and 86356C.
Consumers who have these specific trays should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Regard Dressing Change Tray
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Trays
- Affected units
- 272
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)
- Lot Numbers: 86983C
- 87081C and 86356C.
Distribution
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