Events

Rappel de Device Recall Agilis

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 Sterilmed 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
    77470
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0213-2018
  • Date de mise en oeuvre de l'événement
    2017-06-02
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156097
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Inadequate seal due to lack of adhesive glue.
  • Action
    Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078.

Device

Device Recall Agilis
  • Modèle / numéro de série
    Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
  • Description du dispositif
    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. || Product Usage: || The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Adresse du fabricant
    Sterilmed Inc, 5010 Cheshire Pkwy N Ste 2, Minneapolis MN 55446-4101
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA