Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Recall
- Recall Number
- Z-1680-2022
- Event Number
- 90724
- Firm
- BALT USA, LLC
- FEI Number
- 3014162263
- Product Code
- HCG
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 26, 2022
- Address
- 29 Parker, Ste 100, Irvine, CA, 92618-1667
Description
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
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.
On or about 07/15/2022, Balt USA LLC communicated an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" Letter informing customers that Balt became aware that finished goods were released and distributed to customers prior to the approval and release of a test report authorizing the use of existing material from an alternate supplier. On 08/08/2022 and updated/revised "URGENT MEDICAL DEVICE RECALL" letter was sent via certified mail to customers re-emphasizing the recall and providing updated instructions Customer are instructed to: -Inform within their hospital safety officers, pharmacists, head of neuroradiology and the neuroradiology department staff, as well as any other person. -Return to Balt USA any unused product from lot #F220600470: +Collect and put in quarantine the Optima products concerned by this recall and then return them to Balt USA through the usual "RMA" (Return Material Authorization) procedure by contacting Balt USA's Customer Service Department +Keepj informed Balt USA about the status of every unit of Optima products concerned by this recall; +Fulfill the "Notice of receipt" then return to Balt USA via the indicated contact. -If product from lot #F220600470 has been used, no further action is required. For question contact - Quality Department at [email protected] or telephone number 949-788-1443 or Fax Number: 949-788-1444
U.S.: AZ and FL O.U.S.: None
4 devices