FDA (Devices) recall action 83435
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.
Inter-Med LLC is recalling Chlor-XTRA prefilled syringes because the bung may degrade from chemical interaction with the bleach solution.
Inter-Med LLC is recalling Vista Dental CanalClean kits because the rubber bung may degrade when exposed to bleach solution.
Inter-Med LLC is recalling Vista Dental 3% Sodium Hypochlorite syringes because the rubber bung may degrade due to chemical interaction with the solution.
Inter-Med Llc is recalling 582 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.
Inter-Med Llc is recalling 1,992 units of Vista Dental Sodium Hypochlorite syringes because the rubber bung may degrade when exposed to the bleach solution.
Inter-Med Llc is recalling specific lots of Chlor-XTRA prefilled syringes because the rubber bung may degrade when exposed to the bleach solution.