HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous acce
Summary
The FDA issued a Class II for HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access by Access Vascular, Inc. Reason: Product Mislabeled on the outer bag and inner kit Tyvek header bag.
Details
Source
Device Recall
External ID
Z-1155-2023
Action Date
2023-03-01
Status
Ongoing
Category
device
Product Description
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Lot/Code Info: UDI: (01)00850030354020 Lot Number: 11434018
Quantity Affected: 155 units
Reason for Recall
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Distribution
US Nationwide distribution in the states of FL, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Billerica, MA
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 136 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Access Vascular, Inc has 15 FDA actions in our database, including 9 recalls and 6 clearances.
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 (Access Vascular, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Access Vascular, Inc have FDA actions?
Access Vascular, Inc has 15 FDA actions in our database, including 9 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1155-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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