Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
FDA device recall Z-0103-2023 · posted 2022-10-20 · Open, Classified
Recall details
- Recalling firm
- BALT USA, LLC
- Reason for recall
- Product pouch label does not match up with carton label
- 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
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- HCG
- Quantity affected
- 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.
- Date initiated
- 2022-09-07
- Date posted
- 2022-10-20
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Optima Coil System (K200030) | Balt USA, LLC | 2020-02-01 |
| Optima Coil System (K172390) | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018-02-18 |