Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Summary
The FDA issued a Class II for Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS by BALT USA, LLC. Reason: Product pouch label does not match up with carton label.
Details
Source
Device Recall
External ID
Z-0103-2023
Action Date
2022-10-26
Status
Ongoing
Category
device
Product Description
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Lot/Code Info: Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
Quantity Affected: 41 impacted devices
Reason for Recall
Product pouch label does not match up with carton label
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-07
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 184 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-0103-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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