Events

Rappel de Device Recall MMS

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 MMS Sales Corp.

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
    31451
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0760-05
  • Date de mise en oeuvre de l'événement
    2005-02-21
  • Date de publication de l'événement
    2005-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37920
  • 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
    Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
  • Cause
    Partial occlusion in the t-piece resulting in airway obstruction.
  • Action
    The firm initiated the recall on February 21, 2004 by letter to all consignees.

Device

Device Recall MMS
  • Modèle / numéro de série
    Item Number 15867, 15 per case, Lot numbers: 562960904; 566590904;  Item Number 15880, 15 per case, Lot numbers: 564360904, 566230904, 570181004, 571831004, 573201004, 573201004, 575401104, 575401104, 577011104, 577011104, 578951104, 581731104, 582631204, 588431204, 588431204, 589090105, 591180105, 591180105, 593360105, 596220105, 596220105, 597890105, 597890105;  Item Number 12000-1, 7 per case, Lot Numbers: 581041104;  Item Number 15880-30, 15 per case, Lot Numbers: 573401004;  Item Number 40000-1, 20 per case, Lot Numbers: 568891004, 571691004, 581071104, 585381204, 589170105, 591260105, 593990105, 594930105;  Item Number 40200-1, 20 per case, Lot Numbers: 573461004, 573771004, 579661104;  Item Number 40301-1, 20 per case, Lot Numbers: 584241204;  Item Number 40301-1-13, 20 per case, Lot Numbers: 566290904, 569631004, 572811004, 574881104, 574881104, 578021104, 579671104, 585121204, 586721204, 588541204, 591330105, 593810105, 593810105;  Item Number 40301-1-13MM, 20 per case, Lot Numbers: 569211004, 583381204;  Item Number 40301-1-24, 20 per case, Lot Numbers: 564930904, 566300904, 571471004, 572821004, 574891104, 578081104, 580591104, 581691104, 583391204, 586731204, 588551204, 598410105;  Item Number 40301-1-30, 20 per case, Lot Numbers: 570781004, 593640105;  Item Number 40301-1ML, 20 per case, Lot Numbers: 574901104, 594840105;  Item Number 40302-1C24, 20 per case, Lot Numbers: 562980904, 566650904, 570791004;  Item Number 60000-1, 15 per case, Lot Numbers: 591360105;  Item Number 60201-1, 15 per case, Lot Numbers: 566370904, 568921004, 572491004, 573991004, 579691104, 581721104, 586761204, 590200105, 593860105, 595720105;  Item Number 60300-1, 15 per case, Lot Numbers: 594760105;  Item Number 60300-M, 15 per case, Lot Numbers: 568501004, 575711104;  Item Number 60301-1-24, 15 per case, Lot Numbers: 581731104;   Item Number 60301-13042M, 15 per case, Lot Numbers: 564510904, 568511004, 571951004, 573311004, 577181104, 580111104, 584431204, 586601204, 588621204, 589360105, 593490105, 596320105;   Item Number 60302-1HM30-70, 15 per case, Lot Numbers: 565830904, 581791104, 585661204, 589370105, 590210105;  Item Number 72000-50-7589, 15 per case, Lot Numbers: 583451204;  Item Number 72000-75, 15 per case, Lot Numbers: 568521004, 571511004, 571961004, 574971104, 577191104, 578131104, 578131104, 582761204, 584961204, 593870105;  Item Number 72300-1-4-30-70, 15 per case, Lot Numbers: 564950904, 567821004, 572841004, 578141104, 580621104, 583471204, 586771204, 589380105, 591430105, 593880105, 597180105;  Item Number 72301-1, 15 per case, 594880105;   Item Number C4N000D001, 20 per case, 568751004, 574801104, 578781104, 586301204, 591060105, 593660105, 595620105, 596830105, 596950105  Item Number 60301-1304042, 15 per case, Lot Number 597570105
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • Description du dispositif
    Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
  • Manufacturer
    MMS Sales Corp

Manufacturer

MMS Sales Corp
  • Adresse du fabricant
    MMS Sales Corp, 218 Highline Rd, Pharr TX 78577-9726
  • Source
    USFDA