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-2368-2014
  • 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=129262
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • 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 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • 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
    ARTHROSCOPY PACK - || (1) SURGICAL DURAPREP SOLUTION 26ML LIF || (1) ESMARK BANDAGE || (1 ) ELASTIC BANDAGE 6" X 5yds LIF || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG || (1) TUBE SUCTION CONNECTING W X 12' LIF || (1) SHEET EXTREMITY ABS. 125" X 85" SMS || (1) DRAPE LASER CAMERA W/EL || (3) TOWELS ABSORBENT 15" X 20" LIF || (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL || (1) BABY BLANKET IMP. POLY ABS. LIF || (1) NEEDLE HYPODERMIC 20G X 1%'' || (10) GAUZE SPONGES 4" X 4" 16PLY || (1) BLADE SURGICAL #11 CARBON STEEL || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) IMPERVIOUS STOCKINETTE || (1) SHEET DRAPE 42" X 55" LIF || (1) SUTURE BAG FLORAL LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (1) MAYO STAND COVER REINFORCED LIF || (2) GOWN IMPERVIOUS REINFORCED SMS LARGE || (4) STRIPS TAPE || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y || (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP || 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