Summary
The FDA issued a Class I for Regard Dressing change kit, Item Number 800026006 by ROi CPS LLC. Reason: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component m.
Details
Source
Device Recall
External ID
Z-0596-2024
Action Date
2024-01-10
Status
Terminated
Category
device
Product Description
Regard Dressing change kit, Item Number 800026006
Lot/Code Info: UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Quantity Affected: 1830 units
Reason for Recall
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Distribution
US Nationwide distribution in the state of Louisiana.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
Company
Republic, MO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ROi CPS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ROi CPS LLC have FDA actions?
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0596-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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