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U.S. Department of Health and Human Services

Class 2 Device Recall Optima Coil System

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  Class 2 Device Recall Optima Coil System see related information
Date Initiated by Firm September 07, 2022
Date Posted October 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0103-2023
Recall Event ID 90870
510(K)Number K200030  K172390  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Optima Coil System

Model Number OPTI0208CSS10,

Model Number OPTI0308CSS10. Used in endovascular procedures.
Code Information Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
Recalling Firm/
Manufacturer		 BALT USA, LLC
29 Parker Ste 100
Irvine CA 92618-1667
For Additional Information Contact Mr. Moises Colin
949-788-1443 Ext. 765
Manufacturer Reason
for Recall		 Product pouch label does not match up with carton label
FDA Determined
Cause 2		 Error in labeling
Action On 09/07/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via priority mail to customer informing them that Balt USA was informed that one device had information on the pouch label that differed from the information on the carton label. This hazard presents a high risk to patient safety with the possibility that the user could inadvertently select the wrong size coil for a procedure. Distributor/Subsidiaries are instructed to: -Inform customers about this notice. -Return to Balt USA products from Lot #F2206001068 and Lot #F220601089 Direct Customers are instructed to: -Inform within their hospital Safety Office, Pharmacists, Head of Neuroradiology and staff of Recall. -Return to Balt USA products from Lot #F2206001068 and Lot #F220601089 For questions or assistance - contact Balt USA Quality Department at email - QA@baltgroup.com telephone number - 949-788-1443 or Fax 949-788-1444
Quantity in Commerce 41 impacted devices
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HCG and Original Applicant = Balt USA, LLC
510(K)s with Product Code = HCG and Original Applicant = Blockade Medical, LLC (d.b.a. Balt USA)
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