COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Summary
The FDA issued a Class II for COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single by Merit Medical Systems, Inc.. Reason: Custom sheath Introducer contains incorrect needle size.
Details
Source
Device Recall
External ID
Z-1578-2023
Action Date
2023-05-17
Status
Ongoing
Category
device
Product Description
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Lot/Code Info: Lot # H2122096S1; UDI-DI: (00)884450525197
Quantity Affected: 1186 units
Reason for Recall
Custom sheath Introducer contains incorrect needle size
Distribution
US Distribution to state of: Minnesota
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-21
Company
South Jordan, UT
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 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 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 (Merit Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merit Medical Systems, Inc. have FDA actions?
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1578-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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