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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: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

Agency Publication Date: April 26, 2022
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Affected Products

Product: Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.

(1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.

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Product: Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.

(1) Item Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022.

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Product: Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.

Lot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022.

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89875
Status: Resolved
Manufacturer: ROi CPS LLC
Manufactured In: United States
Units Affected: 3 products (290 convenience kits; 1,501 convenience kits; 950 convenience 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.