Summary
The FDA issued a Class II for Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X by Cordis Corporation. Reason: The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may tr.
Details
Source
Device Recall
External ID
Z-2235-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Lot/Code Info: Lot/Batch number 82219442
Quantity Affected: 8 units
Reason for Recall
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-19
Company
Miami Lakes, FL
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 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 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 (Cordis Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis Corporation have FDA actions?
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2235-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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