Regard Dressing Change Kit Recalled Due to Defective Irrigation Solution
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recalls are classified at the highest level, indicating serious potential for harm. Although no illnesses or injuries have been reported in the agency notice, the Class I designation requires a minimum severity score of 4.
Plain-English summary
ROi CPS LLC manufactured and distributed Regard Dressing change kits (Item Number 800026006) containing an irrigation solution component. The irrigation solution component was subsequently recalled by the component manufacturer. Approximately 1,830 units of the affected kits were distributed in Louisiana.
The specific reason for the component recall has not been disclosed in the FDA notice.
Affected lot numbers include: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270. The UDI/DI is 10194717107873. Additional information is available from the FDA.
The recalled product
- Product
- Regard Dressing change kit, Item Number 800026006
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 1,830
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 (10)
- UDI/DI 10194717107873
- Lot Numbers: 98283
- 97591
- 97405
- 97081
- 96961
- 95508
- 94769
- 94435
- 94270
Distribution
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