Recall Z-0012-2020
Inter-Med Llc · initiated June 27, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Codes / lots: 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
Reason for recall
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-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0012-2020
- Initiated
- June 27, 2019
- Posted by FDA
- October 1, 2019
- Terminated
- August 10, 2021
- Product code
- KJJ – Cleanser, Root Canal
- Quantity
- 1992 units
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Recalling firm
- Inter-Med Llc, Racine, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0011-2020 Class II | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL -…The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0013-2020 Class II | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0014-2020 Class II | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF…The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0015-2020 Class II | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0016-2020 Class II | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |
| Z-0017-2020 Class II | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of… | 06/27/2019Terminated |