HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Summary
The FDA issued a Class II for HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 by Access Vascular, Inc. Reason: The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit p.
Details
Source
Device Recall
External ID
Z-1605-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Lot/Code Info: UDI-DI: 00862559000487; Lot Number: 11423949
Quantity Affected: 240 units
Reason for Recall
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Distribution
US distribution to States of: FL, TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-03
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 147 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-1605-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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