The Recall Desk
HighFDA (Devices)·Z-1408-2022·Announced 2022-07-27

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.

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 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
Category
Medical Device — Surgical/Obstetric Kit
Hazard
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.

See all 2 products in this recall →

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