Events

Rappel de Baxter MicroVolume Infusion Set

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 Baxter Healthcare 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
    56718
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0153-2011
  • Date de mise en oeuvre de l'événement
    2010-09-09
  • Date de publication de l'événement
    2010-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94352
  • 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
    set, administration, intravascular - Product Code FPA
  • Cause
    During packaging testing, baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. the pinholes and tears could compromise the sterile barrier properties of the pouch.
  • Action
    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Baxter MicroVolume Infusion Set
  • Modèle / numéro de série
    product 1M8451, lots UR118877, UR131680, UR149245, UR149427, UR156315, UR170274, UR195123, UR203182, UR209668, UR216473, UR287433, UR289793, UR326546, UR341776, UR363952, UR380428, UR09A28067, UR09H11092, UR09J27046, UR104166, UR107383, UR112003, U384354R, U384487R, U390278R, U400804R, U403725R, U417436R, U429415R, U438655R, U467845R, U480681R, U487017R, U502161R, U503854R, U505255R, U513606R, U520411R, U528042R, U537811R, U538066R, U540781R, U548511R, U568410R, U582700R and U585513R
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
  • Description du dispositif
    Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 43" (64 cm), 0.24 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8451 || For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA