Surgical Convenience Kit Recalled Due to Defective Component
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates the most serious level of defect in a medical device, warranting Critical severity per the recall rubric.
Plain-English summary
The regard Operative LAP surgical convenience kit (Item Number 800943001) manufactured by ROi CPS LLC is being recalled. A total of 345 units were distributed in the United States, specifically to Louisiana. The recall was initiated because the kits were manufactured with a component that was subsequently recalled by Nurse Assist. The affected products are identified by UDI/DI 10194717111863 and Lot Numbers 94792, 95613, 96003, and 96845.
This is classified as a Class I recall by the Food and Drug Administration, the most serious classification level for medical devices. Individuals and healthcare facilities that have received these surgical convenience kits should verify their lot numbers against the list provided and discontinue use of any affected units. Contact ROi CPS LLC for information about product return or disposal.
The recalled product
- Product
- regard Operative LAP, Item Number 800943001; surgical convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- device-defect
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 (5)
- UDI/DI 10194717111863
- Lot Numbers: 94792
- 95613
- 96003
- 96845
Distribution
Distribution scope not specified by the agency.
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