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-2397-2014
  • 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=129291
  • 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
    Product code 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391
  • 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
    D & C LAPAROSCOPY PACK - || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT || (1) MAYO STAND COVER REINFORCED UF || (4) DRAPE UTILITY UF || (1) TRAY MAYO SMALL LIF || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SUTURE BAG FLORAL LIF || (1) TUBE SUCTION CONNECT X" X 12' LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF || (1) UTILITY BOWL 32oz. UF || (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX || (2) DRESSING NON ADH TELFA 4 X 3 ST. UF || (1) JELLY LUBRICATING FIVE GRAM || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) *Pk. STERI STRIP LAP SET LATEX || (1) COVER CAMERA W/ELAST UF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF || (4) TOWELS ABSORBENT 15" X 20" UF || (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF || (2) LIGHT SHIELD || (1) DRESSING TEGADERM 4" X 4 %" LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP || (1) SCALPEL WEIGHTED SAFETY #11 || (1) BAG ZIP LOCK || (1) Pk. STRIP STERI CLOSURE W' X 4" LIF || (1) TIME OUT BEACON NON WOVEN ST. UF || (1) BANDAGE GAUZE STRETCH 4" || (1) NEEDLE ULTRA VERES 120MM UF || (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF || (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F || 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