Events

Rappel de Device Recall Sabraset Administration Sets with Auto Clamp

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
    30506
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0386-05
  • Date de mise en oeuvre de l'événement
    2004-11-19
  • Date de publication de l'événement
    2005-01-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36055
  • 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
    A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. this can lead to free-flow of the solution and a possible overdose of medication to the patient.
  • Action
    Urgent Product Recall letters dated 11/19/04 were sent to the direct accounts on the same date via UPS ground. The accounts were informed that free-flow situations were associated with the listed product codes and lot numbers due to a missing platen assembly in the cassette of the solution sets, which could result in an overdose of medication to the patient. The accounts were requested to stop use of the affected lot numbers and product codes and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. Any questions concerning the return process were directed to NCC at 1-866-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837.

Device

Device Recall Sabraset Administration Sets with Auto Clamp
  • Modèle / numéro de série
    Product codes 560500-100 and 560500-250, all lot numbers other than lots produced within the range of 417519 to 499999, or those with an adhesive circular colored sticker (Avery dot) at the top of the individual package on the Tyvek side or on the shipper label.  Any lot numbers from the following obsolete Sabraset product codes are also being recalled: 5600PM, 560100, 560101, 560110, 560111, 560112, 560112-GEL, 560112-L, 560113, 560115, 560116, 560122-L, 561101, 567100, 567100-L, 567112-L, 567122-L, 569100, 569111, 569122, 560200-100, 560522-100
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
  • Description du dispositif
    Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., the following sets were made in Mexico: || a) Sabraset 56050 ¿ 100 Administration Set with 100 mL Bag and Cassette, 56'', Volume 3 mL, 100 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter || b) Sabraset 56050 ¿ 250 Administration Set with 2500 mL Bag and Cassette, 53'', Volume 3 mL, 250 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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