Events

Rappel de Device Recall Baxter Clearlink IV Administration & Extension Sets

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
    31245
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0845-05
  • Date de mise en oeuvre de l'événement
    2005-02-28
  • Date de publication de l'événement
    2005-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-02-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37492
  • 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
    Possible occlusion of the clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
  • Action
    Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits.

Device

Device Recall Baxter Clearlink IV Administration & Extension Sets
  • Modèle / numéro de série
    Product code 2C6255, lot R04J12126;  Product code 2C8428, lot R04J11318; Product code 2C8515, lot R04J12043; Product code 2C8519, lots R04J12076, R04J12159;  Product code 2C8537, lots R04J11128, R04J11201, R04J12027, R04J12084, R04J12183, R04J13033, R04J13116, R04J13173, R04J14031, R04J14098, R04J14130, R04J14155, R04J15061; Product code 2C8546, lot R04J11177;  Product code 2C8571, lot R04J14205;  Product code 2C8606, lot R04J13025;  Product code 2C8612, lot R04J12019;  Product code 2C8632, lot R04J12258;  Product code 2C8634, lot R04J13090;  Product code 2C8819, lots UR241323, UR242560, UR242669; Product code 2C8864, lot UR240697; Product code 2C8865, lots UR241638, UR241786, UR244012;   Product code A2C9801, lots UR244020, UR245647;  Product code 2H8401, lot R04J12068;  Product code 2H8519, lots R04J15053, R04J16010;   Product code 2N8371, lot UR245027;  Product code 2N8373, lot UR243501;  Product code 2N8374, lots UR229138, UR229526, UR230193, UR230193X, UR230433, UR230458, UR240747, UR241059, UR241356, UR241505, UR242065, UR246033;  Product code 2N8378, lots UR229344, UR229781, UR230060, UR241133, UR241661, UR242107, UR242131, UR242362, UR242644, UR244632;  Product code 2N8399, lots UR230128, UR230573, UR231027, UR231704, UR239301, UR239889, UR240200, UR240945, UR241265, UR242081, UR242230, UR243576;
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela.
  • Description du dispositif
    Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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