Recall Z-0011-2020
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 CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Codes / lots: No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047
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-0011-2020
- Initiated
- June 27, 2019
- Posted by FDA
- October 1, 2019
- Terminated
- August 10, 2021
- Product code
- KJJ – Cleanser, Root Canal
- Quantity
- 377 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-0012-2020 Class II | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300The 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 |