Events

Rappel de Device Recall ONQ Silver Dressing

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 Acrymed Incorporated.

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
    60192
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0306-2012
  • Date de mise en oeuvre de l'événement
    2008-06-30
  • Date de publication de l'événement
    2011-11-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104716
  • 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
    The silver dressing, lot h0705j and h0706j may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.
  • Action
    On June 30 2008, the firm e-mailed all affected customers with an Important Product Recall Notification letter. The customers were notified that two lots of SilverDressing may contain dressings that are not properly seated in the foil pouch. The customers were instructed to inspect the inventory, ceased distribution of the affected lots and quaratine the remaining inventory and notify AcryMed. Customers can call AcryMed at 503-624-9830 for any questions about this recall.

Device

Device Recall ONQ Silver Dressing
  • Modèle / numéro de série
    Lot Numbers: H0705J (I-Flow Lots 17055 and 17054) and H0706J (I-Flow Lot 17054). Expiration date: 11/1/2008.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.
  • Description du dispositif
    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. || The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". || Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
  • Manufacturer
    Acrymed Incorporated

Manufacturer

Acrymed Incorporated
  • Adresse du fabricant
    Acrymed Incorporated, 9650 SW Nimbus Ave, Beaverton OR 97008-7171
  • Source
    USFDA