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-2430-2014
  • 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=129324
  • 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
    Cesarean section kit - Product Code OHM
  • Cause
    Customed has determined that there is the possibility that packaging integrity may be compromised on differ 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 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462
  • 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
    CESAREAN PACK - || (1) BABY BLANKET IMP. POLY ABS. || (4) ABSORBENT TOWELS 15" x 20" LIF || (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF || (2) LITE GLOVES LIF || (1) BOWL PLASTIC WITH LID 80 oz. || (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" || (1) UTILITY BOWL 32 oz. || (10) LAP SPONGES PRE-WASHED XRD LIF || (2) PAD OBSTETRICAL XLGE || (1) BABY BEANNIES || (1) MAYO STAND COVER REINFORCED L/F || (1) DRAPE SHEET 41" X 58" SMS LIF || (1) TUBE SUCTION CONNECT. X" X 12' L/F || (1) EAR ULCER SYRINGE 2oz. LIF || (1) RECEIVING BLANKET 100% COTION || (1) YANKAUER SUCT TUBE WITHOUT VENT L/F || (1) UMBILICAL CORD CLAMP || (2) WRAPPER 20"X 20" || (1) DRESSING ISLAND 4" X 10" || (1) SCALPEL# 10 WITH HANDLE S/S || (1) SCALPEL# 20 WITH HANDLE || (1) TABLE COVER REINFORCED 50" X 90" L/F || (1) MAYO TRAY SMALL || (1) MUCUSTRAP 20cc 1 OFr. || (2) GOWN LGE SMS IMPERVIOUS REINFORCED || (1) SURGICAL DURAPREP SOLUTION 26mL L/F || 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