L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Summary
The FDA issued a Class II for L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30c by Argon Medical Devices, Inc. Reason: Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to pr.
Details
Source
Device Recall
External ID
Z-2638-2024
Action Date
2024-08-21
Status
Ongoing
Category
device
Product Description
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Lot/Code Info: UDI-DI: 20886333209938, 00886333209934. Lot: 11563923. Expiration: 2027-03-11
Quantity Affected: 155
Reason for Recall
Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
Distribution
US distribution to the states of: TX, WA, CA, IL
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-14
Company
Athens, TX
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 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 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 (Argon Medical Devices, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Argon Medical Devices, Inc have FDA actions?
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2638-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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