Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Summary
The FDA issued a Class I for Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, ca by Cordis US Corp. Reason: Non-sterile product labeled as sterile was distributed..
Details
Source
Device Recall
External ID
Z-0286-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Lot/Code Info: UDI/DI 10705032025935, Lot Number 18223410
Quantity Affected: 30 devices
Reason for Recall
Non-sterile product labeled as sterile was distributed.
Distribution
US Distribution to: OK
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-26
Company
Miami Lakes, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Cordis US Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis US Corp have FDA actions?
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0286-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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