MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th
Summary
The FDA issued a Class II for MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutan by Angiodynamics, Inc.. Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass .
Details
Source
Device Recall
External ID
Z-1344-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
Product Description
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
Lot/Code Info: UDI: 15051684023108 UPN: H965457671 Lot Number: 5787806 5790679 5795962 5803521 5806728
Quantity Affected: 200 units
Reason for Recall
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Distribution
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-30
Company
Queensbury, NY
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 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 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 (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1344-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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