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U.S. Department of Health and Human Services

Class 2 Device Recall Neria Soft Infusion Set

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  Class 2 Device Recall Neria Soft Infusion Set see related information
Date Initiated by Firm March 05, 2024
Date Posted April 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1544-2024
Recall Event ID 94217
510(K)Number K162812  
Product Classification Set, administration, intravascular - Product Code FPA
Product Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Code Information UDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Recalling Firm/
Manufacturer		 Unomedical A/S
Osted
Aholmvej 1 - 3
Lejre Denmark
For Additional Information Contact
45 48 16 7000
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Unomedical a/s issued an URGENT: VOLUNTARY MEDICAL DEVICE RECALL notice to its sole consignee on 03/05/2024 via email. The notice explained the issue and requested they examine their inventory for affected product and quarantine it pending destruction. The consignee was also directed to notify their customers.
Quantity in Commerce 10,770 units
Distribution US Nationwide distribution in the state of Florida.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S
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