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-2367-2014
  • 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=129261
  • 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
    Obstetrical kit - Product Code OKV
  • 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 900-1030, 18 lots: 112041230 112072809 112093846 112104130 112114918 113026212 113036313 113047310 113057379 113067853 113078668 113109703 131110148 131210674 140111136 140211630 140311913 140513060
  • Classification du dispositif
    Obstetrical and Gynecological 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
    OB PACK - || (1) BABY BLANKET PRINTED || (1) BABY BEANIES || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) LEGGINS W/7'' CUFF 30" X 42" LIF || (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF || (3) TOWEL ABSORBENT 15" X 20" LIF || (1) DRAPE SHEET 41 " X 58" SMS LIF || (2) PAD OBSTETRICAL X-LARGE LIF || (1) RECEIVING BLANKET 100% COTTON || (1) PVP SCRUB 8" STICK SPONGE || (1) FEEDING TUBE BFR, 15" LONG LIF || (1) BOWL PLASTIC 80oz WITH LID || (1) CORD UMBILICAL CLAMP || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (1) SYRINGE 20cc SLIP TIP LIF || (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF || (1) NEEDLE HYPODERMIC 18G X 1% || (1) NEEDLE HYPODERMIC 22G X 1% || (20) GAUZE SPONGE 4" X 4" 16PL Y || (1) EAR ULCER SYRINGE 2oz LIF || (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF || (2) GLOVE MED FREETOUCH VYNIL POWDER FREE || (1) WRAPPER 24" X 24" L/F || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF || 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