Events

Rappel de Dynarex, Evergreen, Mada and Hospitak.

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 Unomedical.

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
    53489
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0040-2010
  • Date de mise en oeuvre de l'événement
    2009-10-06
  • Date de publication de l'événement
    2009-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85663
  • 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
    Manual Pulmonary Resuscitator - Product Code BTM
  • Cause
    In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
  • Action
    Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product. Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.

Device

Dynarex, Evergreen, Mada and Hospitak.
  • Modèle / numéro de série
    Product ID #: 5804; Lot numbers 07-39, 07-49; Product ID #: 12-8709: Lot numbers: 03-46 03-47 04-42 04-43 06-40 06-43 06-46 06-49; Product ID#: 727-E; lot numbers: 03-17 03-19 03-22 03-25 03-28 03-29 03-33 03-34 03-42 03-45 04-05 04-21 04-31 04-33 04-39 04-40 04-41 04-50 04-51 05-17 05-20 05-32 05-34 05-47 06-04 06-13 06-22 06-25 06-30 06-39 06-40 06-47 06-51 07-07 07-08 07-25 07-29 07-34 07-36 07-42 07-44: Denmark: 04-05; Japan: 06-25 06-30; Mexico: 03-02 03-03 03-40 03-42 03-45 04-05 04-19 04-21 04-37 05-32 05-34 05-42 06-04 07-20 07-29 07-34 07-42 07-44 Peru: 02-36; Product ID # 727MM, Czech Republic lot 07-28; Japan: 07-14    Product ID # 2203; lot numbers: 03-19 03-20 03-31 03-32 03-47 04-13 04-19 04-34 04-45 04-46 05-08 Product ID # 727MM, lot codes: Poland: 05-07; Italy: 06-38 07-11; Denmark: 06-04 07-28 07-36
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • Description du dispositif
    Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. || Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
  • Manufacturer
    Unomedical

Manufacturer

Unomedical
  • Adresse du fabricant
    Unomedical, 5701 S Ware Rd, Mcallen TX 78503-7795
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA