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-2311-2014
  • 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=129144
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • 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 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245
  • Classification du dispositif
    Cardiovascular 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
    OPEN HEART TRAY - PACK- || (25) SPONGE LAP PREWASH 18" X 18" XRD L/F || (1) TRAY PLATO LARGE || (3) DRESSING NON ADH TELFA 8 X 3 || (2) BAG GLASSINE PLAIN || (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) COVER TABLE REINFORCED 50" X 90" LIF || (1) NEEDLE HYPODERMIC 27G X 'h" || (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR || (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF || (1) JAR 16oz 500cc GRADUATE MEASURE || (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F || (2) PENCIL CAUTERY HAND SWITCHING LIF || (1) MARKER SKIN RULER || (2) BANDAGE ELASTIC 4" X 5yds LIF || (2) POLISHER CAUTERY TIP LIF || (2) BANDAGE ELASTIC 6" X 5yds LIF || (2) SYRINGE BULB 60cc CLEAR || (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (1) NEEDLE BLADE/KNIFE 3.0mm || (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL || (1) BLADE SHARP ALL ARROUND || (1) BASIN EMESIS 10 IN 700cc || (3) CATHETER 20FR ROB NEL RED RUB || (3) BOWL UTILITY QUART 32oz LIF || (2) CATHETER THORACIC 32FR STRAIGH || (1) LABELS SET, HEPARINE, SALINE, ETC. || (2) SAFETY SCALPEL #10 DISP || (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP || (2) BOWL UTILITY 16oz L/F || (1) WRAPPER 54" X 54" L/F || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" || 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