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-2343-2014
  • 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=129237
  • 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
    Cesarean section kit - Product Code OHM
  • Cause
    Customed has determined that there is the possibility that packaging integrity may be compromised on different 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 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352
  • Classification du dispositif
    Obstetrical and Gynecological 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
    CESAREAN PACK- - || (3) ABSORBENT TOWELS 15" x 20" LIF || (1) PLASTIC BOWL WITH LID 80oz. || (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD || (2) PAD OBSTETRICAL X-LARGE ST. || (1) MAYO STAND COVER REINFORCED LIF || (1) DRAPE SHEET 41" x 58" SMS LIF || (2) TUBE SUCTION CONNECT. Y.." X 12' LIF || (1) EAR ULCER SYRINGE 2oz. LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F || (1) UMBILICAL CORD CLAMP || (1) SURGICAL BLADE #20 CARBON STEEL || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (1) DRESSING ISLAND 4" X 1 0" || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) BABY BLANKET PRINTED || (1) GOWN IMPERVIOUS REINFORCED LARGE SMS || (1) BAG SUTURE FLORAL || 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