Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
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: This is an FDA Class II recall involving a quality/packaging defect where sterile components were mislabeled as nonsterile. The hazard poses a risk of harm (potential infection if components are used when not properly sterilized), but no illnesses or injuries have been reported in the source text, meeting the criteria for High severity.
Plain-English summary
ROi CPS LLC is recalling 40 nonsterile convenience kits (Item #830014016, Lot #92605, expiration 8/31/2023, UDI #10194717110156) because some components that were required to be sterile were packaged in nonsterile kits instead. This packaging error means the kits do not meet their intended specifications.
The affected kits were distributed to customers in Missouri. No illnesses or injuries have been reported to date.
Consumers and healthcare facilities that received these kits should stop using them and contact ROi CPS LLC for instructions on return or replacement. Healthcare providers should consult with their infection control and quality assurance teams regarding any units already distributed or used.
The recalled product
- Product
- Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
- Manufacturer
- ROi CPS LLC
- Affected units
- 40
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 (4)
- Lot #92605
- exp. 8/31/2023
- Item #830014016
- UDI #10194717110156.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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