Events

Rappel de Device Recall Atrapro Antipruritic Hydrogel, 1.5 oz gel tube

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
    64316
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0890-2013
  • Date de mise en oeuvre de l'événement
    2013-02-12
  • Date de publication de l'événement
    2013-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115812
  • 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
    Out of specification result - stability test failure of free available chlorine (fac) which functions as a preservative for the hydrogel. the 13 month test result obtained was 4 ppm fac and the stability specification is >10 ppm fac.
  • Action
    Oculus sent an Urgent Medical Device Recall letter dated February 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue distribution and segregate the affected product. Immediately remove the affected lots of Recall product from the inventory of sales representative, sub contracted distribution and or fulfillment centers. Segregate the affected product in a secure location for return or destruction. If the product was further distributed customers were instructed to notify healthcare professionals of this recall. Customers were also instructed to completed and return the Business Reply Card and fax to 1-415-462-5163. Once the firm receives the affected product the customer would be contacted by an Oculus Representative and provided a Returns Goods Authorization (RGA) number. For questions customers were instructed to call 1-707-559-2445. For questions regarding this recall 707-559-7191, ext 14.

Device

Device Recall Atrapro Antipruritic Hydrogel, 1.5 oz gel tube
  • Modèle / numéro de série
    Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - One distributor in PA
  • Description du dispositif
    Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. || RX only, Professional Sample, Not for Sale. || Pre-printed tube: MS31071, || Shelf carton: PL51091-08 || Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.
  • 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