STRADIS HEALTHCARE, Vein, Item No.682-1732,
Summary
The FDA issued a Class II for STRADIS HEALTHCARE, Vein, Item No.682-1732, by Stradis Medical, LLC dba Stradis Healthcare. Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, w.
Details
Source
Device Recall
External ID
Z-0543-2023
Action Date
2022-12-21
Status
Ongoing
Category
device
Product Description
STRADIS HEALTHCARE, Vein, Item No.682-1732,
Lot/Code Info: UDI/DI (case) M75268217321, UDI/DI (kit)M75268217320, Serial/Lot Numbers: 22230489185
Quantity Affected: 10 units
Reason for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Distribution
US nationwide distribution, and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-02
Company
Peachtree Corners, GA
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 474 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 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 (Stradis Medical, LLC dba Stradis Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stradis Medical, LLC dba Stradis Healthcare have FDA actions?
Stradis Medical, LLC dba Stradis Healthcare has 93 FDA actions in our database, including 93 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0543-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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