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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

ROi CPS LLC: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Agency Publication Date: July 19, 2022
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Affected Products

Product: Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

Lot Numbers:
92534
92612
Product: Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

Lot #92605, exp. 8/31/2023, Item #830014016, UDI #10194717110156.

Lot Numbers:
92605

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90492
Status: Resolved
Manufacturer: ROi CPS LLC
Manufactured In: United States
Units Affected: 2 products (86 kits; 40 kits)
Agency Last Updated: October 6, 2023

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.