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-2428-2014
  • 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=129322
  • 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
    General surgery tray (kit) - Product Code LRO
  • 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 900-2003, 29 lots: 112030702 112041277 112062472 112093923 112103923 112114386 112114472 112125311 113015438 113025954 113026205 113036457 113047011 113047156 113057447 113057696 113057814 113068159 113078779 113089205 113099569 131110221 131110405 131110582 140211725 140211874 140312378 140312461 140412832
  • Classification du dispositif
    General and Plastic Surgery 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
    GENERAL PACK - || CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF || (1) MAYO STAND COVER REINFORCED LIF || ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF || (2) UTILITY BOWL 16 oz. LIF || (1) GLASINE BAG PLAIN || ( 1) SUTURE BAG FLORAL || (4) DRAPE UTILITY WITH TAPE LIF || ( 1) TABLE COVER REINFORCED 50" X 90" LIF || (1) SURGICAL BLADE# 10 STAINLESS STEEL || ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF || ( 1) LAPAROTOMY T DRAPE STD SMS || (2) DRAPE SHEET 41" X 58" SMS LIF || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (1 0) GAUZE 4"X 4" X 4 PLY || ( 1) CAUTERY TIP POLISHER LIF || (5) LAP SPONGES PRE-WASH XRD LIF || ( 1) CAUTERY PENCIL ROCKER SWITCH LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || ( 1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || ( 1) SURGICAL BLADE# 15 CARBON STEEL || ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL || 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