Events

Rappel de Device Recall Colleague CX Infusion Pump

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
    59449
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2958-2011
  • Date de mise en oeuvre de l'événement
    2011-07-22
  • Date de publication de l'événement
    2011-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102820
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    Baxter's service center tested and returned to the user the colleague infusion pump that did not meet psig (pounds-force per square inch) specifications.
  • Action
    Baxter Healthcare Corp. notified the consignee by telephoned on July 22, 2011, with the call documented per the approved call script. A follow-up "URGENT PRODUCT RECALL" notification was sent dated July 25, 2011, reiterating the telephone communication informing them that the COLLEAGUE pump may not have met certain PSIG (Pounds-force per Square Inch) specifications after testing by the Baxter Global Technical Service Center. Both forms of notification identified the affected product, problem description, hazard involved, and actions needed to be taken. The consignee was instructed to locate the device, remove it from service and return it to Baxter by contacting Baxter Global Technical Services at 1-800-843-7867 option 1, to obtain a prepaid UPS label and shipping box. Upon receipt of the returned unit, Baxter will perform the required testing and address any issues through repair or service. The notication instructs the consignee to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter as per the instructions provided. If the recalled product have been distributed to another facility, or if you are a dealers, wholesalers and distributors, the letter request that this communication be forward to the pump owner as appropriate. For any questions regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central time.

Device

Device Recall Colleague CX Infusion Pump
  • Modèle / numéro de série
    Product Code: 2M8161, Serial Number 12020525CC
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution including the state of Minnesota.
  • Description du dispositif
    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. || Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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