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-2327-2014
  • 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 FDE
  • 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 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480
  • Classification du dispositif
  • 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
    LAPAROSCOPY PACK- - || (1) DRAPE LAP ABDOMINAL WITH POUCH || (1) CAMARA DRAPE 9" X 96" LIF || (5) TOWELS ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED || (1) TABLE COVER REINFORCED 50" X 90" || (4) DRAPE UTILITY WITH TAPE || (3) DRAPE SHEET 41" X 58" SMS || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR || (5) LAP SPONGE PREWASH 18" X 18" XRD || (1) GOWN LGE SMS IMPERVIOUS REINFORCED || (2) GOWN X-LARGE SMS IMPERV. REINFORCED || (2) MEDICINE CUP 2oz. || (1) NEEDLE HYPODERMIC 18G X 1% ST. || ( 1) BLADE SURG. # 15 CARBON STEEL || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK || (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR || (1) DRESSING TEGADERM 4" X 4%" || (1) SOLUTION SURGICAL DURAPREP 6mL || (1) TRAY MAYO SMALL || (1) TUBE SUCTION CONNECT. %"X 12' || (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (1) NEEDLE ECLIPSE 22 X 1% || (1) TIME OUT BEACON NON WOVEN ST || 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