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-2366-2014
  • 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=129260
  • 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 900-998, 30 lots: 110102460 110112688 110123134 111010177 111020380 111040983 111051307 111061695 111071843 111082122 111092412 111092562 111102894 111123312 111123473 112020498 112030759 112041367 112072882 112083446 112093766 112114689 112125126 113026063 113036770 113078482 113109886 140111264 140311950 140412910
  • 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
    C-SECTION PACK - || (1) TABLE COVER REINFORCED 50" X 90" L/F || (3) TOWELS ABSORBENT 15" X 20" L/F || (1) BABY BLANKET || (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV || (2) PAD OBSTETRICAL XL LIF || (1) LITE GLOVE LIF || (1) DRAPE SHEET 41" X 69" MEDIUM LIF || (2) SURGICAL BLADE #10 CARBON STEEL || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (1) BAG GLASSINE || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR || (1) CONTAINER 64oz WITH LID || (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF || (1) MAYO STAND COVER REINFORCED UF || (1) BAG SUTURE FLORAL || (15) LAP SPONGES PRE-WASH XRD LIF || (1) EAR ULCER SYRINGE 2oz UF || (1) CORD UMBILICAL CLAMP L/F || (1) WASH BASIN ?QT. || (1) CAUTERY TIP POLISHER LIF || (1) YANKAUER SUCTION TUBE W/0 VENT LIF || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) FEEDING TUBE 8FR. 15" LONG || (4) DRAPE UTILITY WITH TAPE UF || (1) TUBE SUCTION CONNECT. Y." X 12' UF || (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV || 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