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CHX Plus

Vista Dental · Model 503650 · UDI-DI 10818207020342

KJJ Prescription
10
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities

Description

Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifiers to improve the depth of penetration and kill bacteria. Use prior to restorative preparations of crowns and composites. 30mL Bulk Syringe Includes: (1) 30mL prefilled bulk syringe & (1) docking port

Recalls

DateFirmReason
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.