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-2375-2014
  • 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=129269
  • 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 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475
  • 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 PACK - || (1) CAUTERY TIP POLISHER LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) INSTRUMENT POUCH || (10) LAP SPONGE PRE-WASH XRD || (1) Pk. SURGICAL STRIP W' X 6" || (2) UTILITY BOWL 32oz || (1) MAYO TRAY LARGE || (9) SHEET DRAPE 41 " X 69" MEDIUM LIF || (1) NEEDLE HYPODERMIC 18G X 1 LIF || (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (2) Pr. SURGICAL GLOVES 7 Y2 || (2) Pr. SURGICAL GLOVES 8 || (2) EAR ULCER SYRINGE 2oz LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) SHEET MINOR LAP 102" X 121" X 78" || (1) SAFETY SCALPEL #10 || (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF || (4) CLOTH HUCK TOWELS BLUE || (1) PENCIL CAUTERY ROCKER SWITCH || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) DRAPE% ECONOMY 53" X 77" LIF || (1) Pk. SURGICAL STRIP 'X" X 6" || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F || (2) ROUND WASH BASIN 6QT || (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE || (2) Pr. SURGICAL GLOVES 7 || (1) SKIN MARKER WITH RULER LIF || (1) Pk. STERI STRIP CLOSURE %"X 4" LIF || (1) TUBE SUCTION CONNECT. 'X" X 12' LIF || (1) SAFETY SCALPEL #15 || (1) SAFETY SCALPEL #11L/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