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-2347-2014
  • 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=129241
  • 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
    Product code 900-741A, 2 lots: 140412701 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736
  • 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
    ORTHO IMPLANT SURGICAL PACK - || (1) CAUTERY TIP POLISHER || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" || (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" || (1) TUBE SUCTION CONNECT. }4" X 12' || (1) DURAPREP SURGICAL SOLUTION 26ml || (1) BAG GLASSINE || (1) YANKAUER SUCTION TUBE WITHOUT VENT || (2) LITE GLOVE || (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS || (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE || (1) STOCKINETTE IMPERVIOUS 14" X 48" || (1) MAYO STAND COVER REINFORCED || (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" || (5) ABSORBENT TOWELS 15" X 20" || (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV || (4) DRAPE UTILITY || (1) CAUTERY PENCIL ROCKER SWITCH || (5) LAP SPONGES PREWASH XRD || (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE || (2) DRAPE SHEET 70" X 100" STD SMS || (1) TIME OUT BEACON NON WOVEN || (1) STAPLE SKIN WIDE 35 ST. || (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER || (1) MAYO TRAY LARGE || (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG || (1) TOP DRAPE W/ADHES. 100" X 53" SMS || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP || (2) BANDAGE ELASTIC 6" X 5"yds || (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK || (1) UTILITY BOWL 16oz || (1) NEEDLE HYPODERMIC 18G X 1Y2 || (2) UTILITY BOWL 32oz || (2) BLADE SURGICAL# 10 STAINLESS STEEL || 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