Events

Rappel de Device Recall Anesthesia 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
    30715
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0443-05
  • Date de mise en oeuvre de l'événement
    2004-12-20
  • Date de publication de l'événement
    2005-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-05-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36446
  • 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
    The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
  • Action
    Urgent Product Recall letters dated 12/20/04 were sent to the direct accounts on the same date via next day air. The accounts were informed that the sets were incorrectly labeled as anti-siphon sets and were requested to immediately discontinue use of the affected lot numbers of product code 2C9216 and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. A matrix containing key attributes of product code 2C9216 and two other product codes was provided for consideration of alternates to the recalled product. Any questions concerning the return process were directed to NCC at 1-800-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837. Wholesalers were requested to conduct sub-recalls from their sub-accounts.

Device

Device Recall Anesthesia Set
  • Modèle / numéro de série
    lots UR192765, UR192815, UR192856, UR194290, UR200097, UR200964, UR203109, UR204693, UR208017, UR208116, UR208371, UR209569, UR209791, UR213769, UR215699, UR217141, UR218172, UR218560, UR218669, UR218982, UR222679, UR224584, UR225227, UR227884, UR228353, UR229310, UR232892, UR233841, UR234443, UR234666, UR236554, UR236588, UR239087
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan
  • Description du dispositif
    Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar; 60 sets per case
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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