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-2528-2014
  • 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=129571
  • 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

Device Recall Customed
  • Modèle / numéro de série
    900-3178, 4 lots: 131210899 140211837 140312152 140513143
  • Classification du dispositif
    Gastroenterology-Urology 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
    Laparoscopy pack, , Code 900-3178, contains: || (1) BULB SYRINGE 60cc LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV || (4) TOWEL ABSORBENT 15" X 20" LIF || (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF || (3) LITE GLOVE LIF || (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" || (1) BLADE SURGICAL# 11 || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) SUTURE BAG FLORAL L/F || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF || (1) CABLE LAP 10FR 4MM MALE MONOP. LIF || (1) SPECIMEN CONTAINER 4oz W/LID & LABEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF || (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF || (1) WRAPPER 24" X 24" LIF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) TROCAR ENDO.XCELL DILATING TIP 11 MM || (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF || (1) CANNULA 5MM XCEL SLEEVES LIF || (2) DENTURE CUP 8oz W/LID || (2) DRESSING NON ADH TELFA 4" X 3" || (1) CHLORAPREP 26ML APPLICATOR TEAL LIF || 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