Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Summary
The FDA issued a Class II for Neria Soft Infusion Set, Product Code 507302, intravascular administration set by Unomedical A/S. Reason: Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) .
Details
Source
Device Recall
External ID
Z-1544-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Lot/Code Info: UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Quantity Affected: 10,770 units
Reason for Recall
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
Distribution
US Nationwide distribution in the state of Florida.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-05
Company
Lejre
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 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Unomedical A/S has 6 FDA actions in our database, including 6 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 (Unomedical A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unomedical A/S have FDA actions?
Unomedical A/S has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1544-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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