Reported May 4, 2022 · Terminated
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013,…
ROi CPS LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
- Convenience
- kits containing regard IV Start Kits(1) regard Clinical Packaging Solutions
- Item Number
830015013LD00200M - Vag Delivery Motherand (2) regard Clinical Packaging Solutions
- Item Number
830084003LD00866C - Vag Delivery Mother
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 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) 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. - Amount recalled
- 1,501 convenience kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- MO
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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