HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Summary
The FDA issued a Class II for HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 by Access Vascular, Inc. Reason: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of .
Details
Source
Device Recall
External ID
Z-1131-2023
Action Date
2023-02-22
Status
Ongoing
Category
device
Product Description
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Lot/Code Info: UDI-DI: (01)00862559000456; Lot Number: 11398679, 11416178
Quantity Affected: 302 HydroPICC devices
Reason for Recall
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Distribution
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-16
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 157 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-1131-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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