Summary
The FDA issued a Class II for Optima Coil System Model OPTI0520CSF10. For endovascular embolization. by BALT USA, LLC. Reason: Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate s.
Details
Source
Device Recall
External ID
Z-1680-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Lot/Code Info: Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
Quantity Affected: 4 devices
Reason for Recall
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Distribution
U.S.: AZ and FL O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-26
Company
Irvine, CA
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 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 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 (BALT USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BALT USA, LLC have FDA actions?
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1680-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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