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-2512-2014
  • 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=129545
  • 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
    Orthopedic tray - Product Code OJH
  • 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
    Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795
  • Classification du dispositif
    Orthopedic 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
    TLIF PACK || SURGICAL CENTER, CODE 900-2918. || CONTENTS: || (2) SOLUTION SURGICAL DURAPREP 26ML UF || (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF || (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF || (4) TOWELS ABSORBEN 15" X 20" LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (4) DRAPE% 60" X 76" REINFORCED L/F || (1) DRAPE CHEST 100" X 142" X 72" LIF || (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF || (2) LITE GLOVE LIF || (2) TUBE SUCTION CONNECT. Y." X 12' UF || (12) TOWELS CLOTH HUCK BLUE LIF || (1) UTILITY BOWL QUART 32oz || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF || (1) STERI STRIP DRAPE LARGE 17" X 23" LIF || (1) SKIN MARKER WITH RULER UF || (9) LABELS FOR SKIN MARKERS 1.25 X Y2 || (1) RULER || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) BULB SYRINGE 60cc LIF || (4) NEEDLE HYPODERMIC 18G X 1Y2 UF || (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF || (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF || (1) BLADE SURGICAL # 10 CARBON STEEL || (1) BLADE SURGICAL # 15 CARBON STEEL || (1) TIME OUT BEACON NON WOVEN UF || (2) DRESSING TEGADERM 4" X 4% "UF || (2) MEDICINE CUP 2oz || (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" 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