Inter-Med Llc

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 7

Known Identifiers & Locations

FEI Numbers 3000209941
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (7)

Recall # Product Description Initiation Date Status Action
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 Reason: 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. 2019-06-27 Terminated View Details
Z-0012-2020 Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 Reason: 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. 2019-06-27 Terminated View Details
Z-0013-2020 Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315 Reason: 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. 2019-06-27 Terminated View Details
Z-0014-2020 Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 Reason: 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. 2019-06-27 Terminated View Details
Z-0015-2020 Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355 Reason: 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. 2019-06-27 Terminated View Details
Z-0016-2020 Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825 Reason: 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. 2019-06-27 Terminated View Details
Z-0017-2020 Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 Reason: 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. 2019-06-27 Terminated View Details

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