Events

Rappel de Device Recall Puracyn OTC Wound & Skin Care 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-0449-2012
  • 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=105228
  • 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 Puracyn OTC Wound & Skin Care Solution
  • Modèle / numéro de série
    Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12.  Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12;  081710-01, exp.9/11;  120810-01, exp 2/2012; 073010-02, exp 11/11.  Part number: 6004; 80005. 16 oz with insert:  061511-02. exp 12/12.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Puracyn OTC; || Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. || Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. || Does not contain Antibiotics, Steroids or Alcohol. || -Cleans infected wounds in one step || - Safe to use around eyes, nose, m mouth and open wounds || - Accelerated healing of minor wounds by keeping the wound clean || -Non-toxic and non-irritating. || Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. || 3546 N. Riverside Ave. Rialto, CA 92377 || Made in USA. || Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
  • 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