Device recall: Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga…
Class II FDA enforcement event 83435. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Inter-Med Llc started this device recall on 27 Jun 2019. The firm address in the FDA record is in Racine, WI. FDA put the recall in Class II. FDA event 83435 has 7 product records. The first FDA enforcement report date is 9 Oct 2019. The record gives the status Terminated, with the termination date 10 Aug 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Recalling firm
Inter-Med Llc, Racine, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0011-2020 | 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 | 377 units | Class II | Terminated | 9 Oct 2019 |
| Z-0012-2020 | Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 | 1992 units | Class II | Terminated | 9 Oct 2019 |
| Z-0013-2020 | Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 | 582 units | Class II | Terminated | 9 Oct 2019 |
| Z-0014-2020 | Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 | 768 units | Class II | Terminated | 9 Oct 2019 |
| Z-0015-2020 | Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 | 445 units | Class II | Terminated | 9 Oct 2019 |
| Z-0016-2020 | Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 | 58 units | Class II | Terminated | 9 Oct 2019 |
| Z-0017-2020 | Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 | 384 units | Class II | Terminated | 9 Oct 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 7
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 May 2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 Event 99105 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0011-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83435. https://recallregister.com/fda/ii/83435/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- What quantity of product is in FDA event 83435?
- The event has 7 product records. The first record gives this quantity:
377 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.