Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc
Summary
The FDA issued a Class II for Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ste by Medical Action Industries, Inc. 306. Reason: The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits..
Details
Source
Device Recall
External ID
Z-0464-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product Description
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
Lot/Code Info: Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.
Quantity Affected: 24 cases (480 kits)
Reason for Recall
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Distribution
Distribution was made to MN. There was no foreign/government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-12
Company
Arden, 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 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 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 (Medical Action Industries, Inc. 306) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Action Industries, Inc. 306 have FDA actions?
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0464-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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