Summary
The FDA issued a Class III for Regard Custom Procedure Kits containing BD Luer Lok Access Devices by ROi CPS LLC. Reason: Recalled devices were packaged in convenience kits..
Details
Source
Device Recall
External ID
Z-0837-2022
Action Date
2022-04-06
Status
Terminated
Category
device
Product Description
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Lot/Code Info: IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)
Quantity Affected: 1750 kits
Reason for Recall
Recalled devices were packaged in convenience kits.
Distribution
US Nationwide distribution in the state of Missouri.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-24
Company
Republic, MO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 123 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0837-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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