Events

Rappel de Device Recall SurgiWrap

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 MAST Biosurgery USA, 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
    70051
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1076-2015
  • Date de mise en oeuvre de l'événement
    2014-08-26
  • Date de publication de l'événement
    2015-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132886
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Cause
    The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. the printed expiration date was august of 2017, while the bar code date read as july 31, 2017. the correct expiration date was july 31, 2017.
  • Action
    MAST Biosurgery labeled 49 new envelopes and sent them to the distributor, and subsequently had the distributor remove the contents of the outer envelope (instructions for use and the foil pouches containing the product) and place them into the newly supplied and properly labeled outer envelopes provided by them. The distributor requested to send back the original 49 enveloped. The second batch of new labels was inspected and attached to the new outer envelope to create a properly labeled outer envelope prior to shipping. The firm requested that once the distributor replaced the product and the IFU into the newly labeled envelopes that they provide documentation that the product had been repackaged into the new envelopes. The distributor was also requested to verify that they did not ship any product to customers with the incorrect label. The firm had the distributor return the 49 improperly with the incorrect labels and the first set of "corrected" labels to them for destruction. Further questions call (858) 550-8050.

Device

Device Recall SurgiWrap
  • Modèle / numéro de série
    LOT 52804 2017-08
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution to the country of China.
  • Description du dispositif
    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm || (01) 18964050255027 || (17) 170731(10)52804 || LOT 52804 2017-08 REF25502-01 || Product is wrapped in a foil pouch that is then sealed into an additional envelope.
  • Manufacturer
    MAST Biosurgery USA, Inc

Manufacturer

MAST Biosurgery USA, Inc
  • Adresse du fabricant
    MAST Biosurgery USA, Inc, 6749 Top Gun St Ste 108, San Diego CA 92121-4151
  • Société-mère du fabricant (2017)
    Mast Biosurgery Usa Inc.
  • Source
    USFDA