IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Summary
The FDA issued a Class II for IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile by Medical Action Industries, Inc. 306. Reason: The kits contain saline flush syringes which were recalled by the supplier..
Details
Source
Device Recall
External ID
Z-1394-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Lot/Code Info: Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Quantity Affected: 206,200 kits
Reason for Recall
The kits contain saline flush syringes which were recalled by the supplier.
Distribution
US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-15
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 163 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-1394-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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