Events

Rappel de Device Recall Microcyn Solution

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Oculus Innovative Sciences Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60387
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0448-2012
  • Date de mise en oeuvre de l'événement
    2011-11-09
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105226
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Dressing, wound,drug - Product Code FRO
  • Cause
    Unapproved drug claims and those not approved under 510k clearance.
  • Action
    Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.

Device

Device Recall Microcyn Solution
  • Modèle / numéro de série
    Part number: 84798; - 500 mL Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 11C0130, exp 2/13.  Part number 84781: - 990 mL lot numbers: OIS00012-01, exp 1/12; OIS00012-02, ecp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) || Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) || -Non Foaming || -Does not contain antibiotics || - Does not facilitate resistance || - No known drug/treatment interactions or contraindications || -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. || Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. || Oculus Innovative Sciences' || Petaluma, CA 94954. || Intended to be used by health care professionals in the management in wounds.
  • Manufacturer
    Oculus Innovative Sciences Inc

Manufacturer

Oculus Innovative Sciences Inc
  • Adresse du fabricant
    Oculus Innovative Sciences Inc, 1129 N Mcdowell Blvd, Petaluma CA 94954-1110
  • Société-mère du fabricant (2017)
    Sonoma Pharmaceuticals Inc.
  • Source
    USFDA