Events

Rappel de RAPIDFILL Syringe Strip

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 Corporation Englewood.

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
    68030
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1620-2014
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Date de publication de l'événement
    2014-05-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126818
  • 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
    Syringe, piston - Product Code FMF
  • Cause
    Possible breach in sterile barrier for inner and outer bags of the product.
  • Action
    Baxter sent an Urgent Product Recall letter dated April 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. To return the affected product, receive credit and order replacement, please contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00am and 6:00pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. If you have questions regarding the content of this communication, please call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00am to 5:00 pm Central Time, Monday through Friday.

Device

RAPIDFILL Syringe Strip
  • Modèle / numéro de série
    Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.
  • Description du dispositif
    RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Adresse du fabricant
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA