Events

Rappel de Device Recall Customed

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 Customed, 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
    68536
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2429-2014
  • Date de mise en oeuvre de l'événement
    2014-05-20
  • Date de publication de l'événement
    2014-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129323
  • 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
    laparoscopy kit - Product Code FDE
  • Cause
    Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

Device Recall Customed
  • Modèle / numéro de série
    Product code 900-2004, 11 lots: 112030703 112061278 112114387 112114491 112114877 113068160 113078570 113089022 113099283 131110222 140613472
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Description du dispositif
    LAPAROSCOPY CHOLE PACK - || (6) TOWELS ABSORBENT 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED L/F || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (1) SURGICAL BLADE #11 CARBON STEEL || (1) TUR Y SET, 2LEAD L/F || (4) DRAPE UTILITY WITH TAPE LIF || (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) || (1) ULTRA VERES NEEDLE 120mm || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF || (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" || (2) DRAPE SHEET 41" X 58" SMS || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F || (5) LAP SPONGE PREWASH XRD LIF || (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF || (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) || (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF || (1) SURGICAL DURAPREP SOLUTION 26ML LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA