6% NaOCL Sodium Hypochlorite recallZ-0012-2020 · Inter-Med Llc · initiated Jun 27, 2019
Class II Terminated All recalls posted in October 2019
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Inter-Med Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
FDA root cause category: Process control
What the company is doing
The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.
Recall details
- Recall number
- Z-0012-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 27, 2019
- Posted by the FDA
- Oct 1, 2019
- Recalling firm
- Inter-Med Llc
- Quantity
- 1992 units
- Product code
- KJJ
- FDA submissions
- K082470
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Product description
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Code information (models, lots, serial numbers)
Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 6% NaOCL Sodium Hypochlorite 502300Vista Dental · Cleanser, Root Canal1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 83435).
- Z-0013-2020 · TerminatedVista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
- Z-0014-2020 · TerminatedVista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
- Z-0015-2020 · TerminatedVista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
- Z-0016-2020 · TerminatedVista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
- Z-0017-2020 · TerminatedVista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page