Events

Rappel de Device Recall MAQUET

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 Maquet Cardiovascular Us Sales, Llc.

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
    67515
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1165-2014
  • Date de mise en oeuvre de l'événement
    2014-01-31
  • Date de publication de l'événement
    2014-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125652
  • 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
    Heat-exchanger, cardiopulmonary bypass - Product Code DTR
  • Cause
    The maquet post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the plegiox cardioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler unit.
  • Action
    Maquet Inc.sent an" Field Safety Notice" dated January 31, 2014, to all affected customers via Fed Ex. The letter identified the product the problem and the action needed to be taken by the customer. Any questions or additional information, can be obtained from the MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (press option 2, followed by option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Please complete and return the enclosed confirmation form, acknowledging your receipt and understanding of this communication, by emailing a scanned copy to Fieldactions@maquet.com or via fax at (973) 807-9290.

Device

Device Recall MAQUET
  • Modèle / numéro de série
    Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15929-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16115-06 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16346-06 70105.0967 BO-T 1260 Adult Cardioplegia Pack 15760-07 70105.0975 BO-TOP 26300 Custom Pack 15796-13 70105.1736 BEQ-TOP 4903 Open Heart Pack 15921-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16073-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16153-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16321-07 70105.1861 BO-TOP 14601 Open Heart Tubing Pack 15880-02 70105.2463 BO-T 25102 Custom Pack 15755-07 70105.2463 BO-T 25102 Custom Pack 15889-07 70105.2463 BO-T 25102 Custom Pack 16046-07 70105.2463 BO-T 25102 Custom Pack 16155-07 70105.2463 BO-T 25102 Custom Pack 16267-07 70105.2650 BO-TOP 23102 Scott &White; OR CPB Pack 15818-10 70105.2659 BO-TOP 4903 Adult Open Heart Pack 15780-03 70105.2659 BO-TOP 4903 Adult Open Heart Pack 16047-03 70105.3832 BO-TOP 32400 Adult CPB Pack 15814-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16063-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16449-06 70105.5015 BO-TOP 36500 Cardiac Surgery 15658-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15772-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15883-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16078-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16250-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16410-17 70105.6041 BEQ-T 4906 Pediatric CPB Pack w/o VKMO 15819-02 70105.6238 BO-TOP 38800 Open Heart Pack 15635-05 70105.6238 BO-TOP 38800 Open Heart Pack 16013-05 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16039-09 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16238-10 70105.6869 BO-TOP 4113 Pediatric 1/4x3/8 15574-03 70106.2237 T 24260 St Louis Children¿s Cardioplegia 15659-05 70106.2237 T 24260 St Louis Children¿s Cardioplegia 15967-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 15892-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 16122-07 70106.2707 BEQ-TOP 40000 Open Heart Pack 16224-07 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15783-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15923-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15998-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16239-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16387-05 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15845-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15976-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 16120-03 70106.3623 BO-T 31261 Plegiox Pack 15800-04 70106.3623 BO-T 31261 Plegiox Pack 15924-04 70106.3623 BO-T 31261 Plegiox Pack 16112-04 70106.3623 BO-T 31261 Plegiox Pack 16145-04 70106.3623 BO-T 31261 Plegiox Pack 16184-04 70106.4327 BO-TOP 48400 OR Pack 16169-01 70106.4327 BO-TOP 48400 OR Pack 16310-01 70106.5315 BEQ-T 16403 Liver TX 16114-06 70106.6206 BEQ-TOP 38307 Adult Pack 15931-03 70106.6398 BEQ-TOP 48000 Open Heart WITH Oxygenator 15932-02 70106.6400 BEQ-TOP 48001 Open Heart WITH OXY 15933-02 70106.6461 BEQ-TOP 38310 Small Adult Pack 15934-02 70106.6664 BEQ-T 4903 Open Heart Pack with NO VKMO 16040-01 70106.6712 BO-T 14601 Open Heart WITHOUT VKMO 16067-01 70106.6713 BEQ-T 40000 Open Heart WITHOUT VKMO 16056-01 70106.6738 BO-T 26300 Transitional Cardiac Surgery Pk 16146-01 70106.6914 BEQ-T 4961 Cardioplegia Pack 4:1 16240-01
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
  • Description du dispositif
    MAQUET PLEGIOX Cardioplegia Heat Exchanger || The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA