HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Summary
The FDA issued a Class II for HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 by Access Vascular, Inc. Reason: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the fo.
Details
Source
Device Recall
External ID
Z-0115-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
Product Description
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Lot/Code Info: UDI-DI: 00850030354068; Lot Number: 11469666
Quantity Affected: 58 total
Reason for Recall
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Distribution
US Nationwide distribution in the states of IL, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-31
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 141 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-0115-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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