Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD
Summary
The FDA issued a Class II for Convenience kits containing regard IV Start Kits: (1) regard Clinical Packagi by ROi CPS LLC. Reason: 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..
Details
Source
Device Recall
External ID
Z-1005-2022
Action Date
2022-05-04
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: (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.
Quantity Affected: 1,501 convenience kits
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of Missouri.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-18
Company
Republic, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ROi CPS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ROi CPS LLC have FDA actions?
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1005-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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