Events

Rappel de Device Recall Cardinal Steam Biological Indicator

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 Steritec Products Mfc. Co., 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
    65473
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1823-2013
  • Date de mise en oeuvre de l'événement
    2013-06-10
  • Date de publication de l'événement
    2013-07-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119709
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Cause
    Mesa labs, based out of bozeman, mt, informed steritec products, inc. of a product recall involving the eztest steam and smart-read biological indicators (bi) because the readout time is not in specification with the label claims.
  • Action
    The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: Jon@SteriTecproducts.com or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot number printed on the packaging components; place affected items in hold and do not sell or distribute these lots; record inventory of all items remaining in your warehouse and all items that have been distributed; advise SteriTec of the status of all inventory you received used or unused, if you have distributed the affected product to other locations within your healthcare system, notify them immediately of this recall, ask them to provide inventory status and proceed with destruction or return via instructions provided in letter-If you have shipping questions, please contact SteriTec directly at 303-660-4201, or email us at: Info@SteriTecproducts.com, and also provide this notice to anyone in your facility that needs to be informed. Should you have any questions or concerns, please do not hesitate to contact Director of Regulatory Affairs and Quality Assurance or our offices at 303-660-4201. SteriTec's hours of operation are 7:30am Mountain Standard Time (MST) through 5:00pm MST.

Device

Device Recall Cardinal Steam Biological Indicator
  • Modèle / numéro de série
    Affected Biological Indicator Lot No.: S-444
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
  • Manufacturer
    Steritec Products Mfc. Co., Inc.

Manufacturer

Steritec Products Mfc. Co., Inc.
  • Adresse du fabricant
    Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
  • Société-mère du fabricant (2017)
    Steritec Product Mfg. Co. Inc.
  • Source
    USFDA