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-2387-2014
  • 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=129281
  • 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
    Neurological tray - Product Code OJG
  • 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 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • 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
    NEURO SPINE PACK - || (1) BAG SUTURE FLORAL || (1) COVER TABLE 44" X 90" || (4) ABSORBENT TOWELS 15" X 20" UF || (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS || (4) DRAPE UTILITY WITH TAPE LIF || (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP || (1) DURAPREP SURGICAL SOLUTION 26mL UF || (1) INCISION DRAPE 23" x 17" || (1) INSTRUMENT POUCH || (2) CAUTERY TIP POLISHER LIF || (1) CAUTERY PENCIL HANDSWITCHING LIF || (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF || (2) LITE GLOVES LIF || (1) TUBE SUCTION CONNECT. Y.." X 12' LIF || (1) SKIN MARKER WITH RULER || (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF || (1) Pk SURGICAL STRIP W'X 6" || (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F || (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF || (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL || (5) DRAPE % ECONOMY 53" X 77" LIF || (2) TABLE COVER HD 77" X 110" L!F || (1) MAYO TRAY LARGE || (1) UTILITY BOWL 16 oz LIF || (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F || (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF || (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL || (1) J VAC RESERVOIR 300 mL || 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