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Optima Coil System recallZ-1680-2022 · Balt USA, LLC · initiated Jul 26, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Balt USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1680-2022
Status
Open, Classified
Initiated by the company
Jul 26, 2022
Recalling firm
Balt USA, LLC
Quantity
4 devices
Product code
HCG
FDA submissions
K172390, K200030
Distribution
U.S.: AZ and FL O.U.S.: None

Product description

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

Code information (models, lots, serial numbers)

Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

399 devices cleared under K172390, K200030 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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