Summary
The FDA issued a Class II for Regard, T AND A - Rogers, sterilized convenience kits by ROi CPS LLC. Reason: Kits lacks rubber latex warning label..
Details
Source
Device Recall
External ID
Z-0469-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
Regard, T AND A - Rogers, sterilized convenience kits
Lot/Code Info: 1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023
Quantity Affected: 195 kits
Reason for Recall
Kits lacks rubber latex warning label.
Distribution
US Nationwide distribution in the state of MO.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-30
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 106 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-0469-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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