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-2389-2014
  • 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=129283
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • 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 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718
  • Classification du dispositif
    Cardiovascular 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
    OPEN HEART TRAY - - PACK A || ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF || (5) DRAPE % ECONOMY 53" X 77" LIF || ( 1) MAYO STAND COVER REINFORCED LIF || (7) DRAPE UTILITY WITH TAPE L/F || (8) HUCK CLOTH TOWELS WHITE L/F || (20) HUCK CLOTH TOWELS BLUE LIF || (1) MAYO TRAY LARGE LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF || (6) 3/4 SHEET DRAPE REINFORCED LIF || (2) STOCKINETTE 9" X 48" LIF || (1) SPLIT SHEET BILATERAL 84" X 80" LIF || (3) DRAPE SHEET 41" X 58" SMS LIF || (4) Pr. GLOVES SURGEON #7 BIOGEL || OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- || (1) PLASTIC RULER 12" LONG || (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F || (1) Pk. PEANUT SPONGE DISSECTOR ST. || (2) UTILITY BOWL 32 oz. LIF || (1) SKIN MARKER WITH RULER LIF || (2) UTILITY BOWL 16 oz. UF || (3) BULB SYRINGE 60cc UF || (1) MAYO TRAY SMALL L/F || (2) YANKAUER SUCT. TUBE WITHOUT VENT UF || (1) TRAY ORGANIZER FULL DEEP LIF || (5) SAPHENOUS VEIN CANNULA LIF || (40) LAP SPONGES PRE-WASH XRD UF || (2) ELASTIC BANDAGE 6" X 5 yds. UF || (2) SUTURE BAG FLORAL || (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF || (1) BLADE SHARP ALL ARROUND 69 || (1) SURGICAL BLADE# 11 CARBON STEEL || (4) LITE GLOVES UF || (2) SURGICAL BLADE# 15 CARBON STEEL || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF || (2) POUCH INSTRUMENT || (2) SURGICAL BLADE# 10 CARBON STEEL || (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF || (2) CAUTERY PENCIL ROCKER SWITCH LIF || (2) POLISHER CAUTERY TIP UF || (1) LABEL SET, HEPARINE,SALINE || (2) ELASTIC BANDAGE 4" X 5 yds. LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF || (2) COTION GLOVE HEAVY DUTY || (1) AORTIC MONITORING PRESS SET 5.0 || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF || (2) NEEDLE HYPODERMIC 22G X 1 % LIF || (1) BLADE 6.1 X 32.3 X 1.0MM || (1) SQUARE TWO PIECE 500cc GRADUATE || (2) CONNECTOR REDUCER || (1) NEEDLE BLADE/KNIFE 3.0MM || 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