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-2338-2014
  • 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
  • Date de fin de l'événement
    2017-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    laparoscopy 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

  • Modèle / numéro de série
    Product code 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456
  • Classification du dispositif
  • 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) MAYO STAND COVER REINFORCED LIF || (1 0) GAUZE SPONGES 4" X 4" 16PL Y || (1) TUBE SUCTION CONNECTING X" X 12' LIF || (1) IMP. STOCKINETTE || (1) SURGICAL BLADE #11 STAINLESS STEEL || (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ || (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF || (2) ELASTIC BANDAGE 6" X 5yrd LIF || (1) TUR Y SET 81 "2.1m REGULAR CLAM || (2) NEEDLE HYPODERMIC 18G X 1 ~ || (1) TABLE COVER 50" X 90" REINFORCED LIF || (5) TOWEL ABSORBENT 15" X 20" LIF || (2) DRAPE UTILITY WITH TAPE LIF || (1) DURAPREP SURGICAL SOLUTION 26m I LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (1) Pr. NEUTRALON SURGEON GLOVES #7.5 || (1) Pr. NEUTRALON SURGEON GLOVES #8 || (1) Pr. NEUTRALON SURGEON GLOVES #8.5 || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS || (10) GAUZE SPONGES 4" X 4" 16PLY XRD || (2) STRIPS TAPE || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF || (1) DRAPE VIDEO CAMERA LIF || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
  • Source
    USFDA