Nonsterile Components in Medical Convenience Kits Recalled
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.
What this means for you
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: This is an FDA Class II medical device recall due to sterility failure. Components required to be sterile were found to be nonsterile, creating a risk-of-harm situation. Without reported injuries in the source and with theoretical hazard, it meets the criteria for High severity per the rubric.
Plain-English summary
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri. The affected products are Item #830099008 (CV01005H - CV Part 1 Bundle, Lot #92534, expires 11/13/2022) and Item #830019017 (CV00214Q - CV, Lot #92612, expires 8/31/2023).
Some components within these kits that were supposed to be sterile were packaged as nonsterile instead.
Customers and distributors who have received these kits should identify the affected products using the lot numbers and expiration dates provided. Contact ROi CPS LLC for instructions on how to handle or dispose of the recalled items.
The recalled product
- Product
- Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
- Manufacturer
- ROi CPS LLC
- Hazard
- sterility-failure
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 (6)
- (1) Item #830099008 - Lot #92534
- exp. 11/13/2022
- UDI #10194717114895
- (2) Item #830019017 - Lot #92612
- exp. 8/31/2023
- UDI #10194717113249.
Distribution
Distributed in 1 state:
- MO
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