Events

Rappel de Device Recall Forteo teriparatide (rDNA origin) injection starter kits

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 Eli Lilly and Company.

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
    58219
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2191-2011
  • Date de mise en oeuvre de l'événement
    2011-03-17
  • Date de publication de l'événement
    2011-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98738
  • 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
    Lubricant, patient - Product Code KMJ
  • Cause
    Eli lilly and company announced 3/17/2011 that patients should not use the alcohol prep pads made by the triad group that are contained in the black starter kits for forteo [teriparatide (rdna origin) injection] in the united states.The tri-ad group is recalling the alcohol prep pads due to potential contamination with the bacteria, ba-cillus cereus, which could result in life threatening infecti.
  • Action
    The firm, Eli Lilly and Company, sent two letters entitled "URGENT MEDICAL DEVICE RECALL TRIAD GROUP ALCOHOL PREP PADS INCLUDED IN FORTEO STARTER KITS ALL ALCOHOL PREP PAD LOTS" to its customers. The first letter was dated March 18, 2011 and second follow-up letter was dated March 28, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to examine their inventory of Forteo starter kits; if they have any Forteo starter kits with a black bag, remove and appropriately discard the Triad Group alcohol prep pads; discontinue providing the product with the starter kits; inform any patients that may have received Forteo starter kits containing the Triad Group alcohol prep pads to discontinue use; note: after removing the Triad Group alcohol prep pads, all other components of the Forteo starter kits are acceptable for use: travel bag, pen case, gel packs, needles and instructional materials, and complete and return the enclosed business reply card. "It is important to note that this recall does not affect or involve the Forteo delivery device." For questions pertaining to the recall, contact Triad Group at 262-538-2900. (Please refer to the Triad Group press release issued on January 5, 2011 on the FDA website.) If you have product specific medical questions related to Forteo please call 1-800-LILLYRX.

Device

Device Recall Forteo teriparatide (rDNA origin) injection starter kits
  • Modèle / numéro de série
    This product is not lot coded and does not have an expiration date. The kits sucject to this recall were distributed between March 2008 and June 2009. Individuals who receive Forteo therapy are generally prescribed for a period of two (2) years.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland.
  • Description du dispositif
    Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. || Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
  • Manufacturer
    Eli Lilly and Company

Manufacturer

Eli Lilly and Company
  • Adresse du fabricant
    Eli Lilly and Company, 1555 S. Harding/Lilly Corporate Center, Drop Code 2622, Indianapolis IN 46285-0001
  • Société-mère du fabricant (2017)
    Eli Lilly & Company
  • Source
    USFDA