Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product
Summary
The FDA issued a Class II for Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introdu by Arrow International Inc. Reason: Marketed without a 510K.
Details
Source
Device Recall
External ID
Z-2069-2021
Action Date
2021-07-21
Status
Ongoing
Category
device
Product Description
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Lot/Code Info: Lot Numbers: 16F20C0035 16F20F0124
Quantity Affected: 5 units
Reason for Recall
Marketed without a 510K
Distribution
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-19
Company
Reading, PA
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.
Arrow International Inc has 55 FDA actions in our database, including 55 recalls.
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 (Arrow International Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arrow International Inc have FDA actions?
Arrow International Inc has 55 FDA actions in our database, including 55 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2069-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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