Events

Recall of Device Recall Microcyn Solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oculus Innovative Sciences Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60387
  • Event Risk Class
    Class 2
  • Event Number
    Z-0448-2012
  • Event Initiated Date
    2011-11-09
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105226
  • Notes / Alerts
    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.
  • Extra notes in the data
    Dressing, wound,drug - Product Code FRO
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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
  • Manufacturer Address
    Oculus Innovative Sciences Inc, 1129 N Mcdowell Blvd, Petaluma CA 94954-1110
  • Manufacturer Parent Company (2017)
    Sonoma Pharmaceuticals Inc.
  • Source
    USFDA