Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Summary
The FDA issued a Class II for Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter by ARROW INTERNATIONAL Inc.. Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits..
Details
Source
Device Recall
External ID
Z-2590-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Lot/Code Info: Batch/Lot number 13F22J0617
Quantity Affected: 190 units
Reason for Recall
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
Morrisville, NC
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 195 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-2590-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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