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-2423-2014
  • 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=129317
  • 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
    General surgery tray (kit) - Product Code LRO
  • 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 900-1966, 18 lots:  113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119
  • Classification du dispositif
    General and Plastic Surgery 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
    HIGADO & PANCREA PACK - || (1) BAG SUTURE FLORAL || (2) YANKAUER SUCTION TUBE WITHOUT VENT || (4) DRAPE UTILITY WITH TAPE || (6) TOWELS CLOTH HUCK BLUE || (1) SHEET DRAPE 41 " X 58" SMS || (1) MAYO TRAY LARGE || (1) TABLE COVER REINFORCED 50" X 90" || (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" || (1) DRAPE BARIATRIC || (1) BLADE SURGICAL #10 STAINLESS STEEL || (1) CUP SPECIMEN WITH CAP 4oz || (1) BLADE SURGICAL #15 STAINLESS STEEL || (30) LAP SPONGE PREWASH 18" X 18" XRD || (1) STRIP STERI CLOSURE W X 4" || (1) POLISHER CAUTERY TIP || (1) NEEDLE ECLIPSE 22 X 1 Y2 || (4) TOWEL ABSORBENT 15" X 20" || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK || (2) LITE GLOVE || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER || (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR || (1) FORCE TRIVERSE || (1) SYRINGE BULB 60CC || (1) BLADE EXTENDED ELECT. 16.51cm || (2) TUBE SUCTION CONNECT Y." X 12' || (2) CHLORAPREP 26ML APPLICATOR TEAL || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE || 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