SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic inten
Summary
The FDA issued a Class II for SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empt by The Metrix Company. Reason: A limited number of IV bags have been found to leak during filling..
Details
Source
Device Recall
External ID
Z-0336-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Lot/Code Info: UDI/DI 50812496011553, Lot Numbers: 66041-A8296, 66041-A8343, 66041-A8386, 66041-A8418, 66041-A8433
Quantity Affected: 2549 cases of 50 units
Reason for Recall
A limited number of IV bags have been found to leak during filling.
Distribution
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-09
Company
Dubuque, IA
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 242 device recalls issued in the same week, part of 403 device-related FDA actions this month.
The Metrix Company has 16 FDA actions in our database, including 16 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 (The Metrix Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Metrix Company have FDA actions?
The Metrix Company has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0336-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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