Recall Z-0103-2023
Balt USA, LLC · initiated September 7, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Codes / lots: Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089
Reason for recall
Product pouch label does not match up with carton label
FDA-determined cause: Error in labeling
Action taken
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
Details
- Recall number
- Z-0103-2023
- Initiated
- September 7, 2022
- Posted by FDA
- October 20, 2022
- Product code
- HCG – Device, Neurovascular Embolization
- Quantity
- 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.
- Recalling firm
- Balt USA, LLC, Irvine, CA