Events

Rappel de Device Recall Baxter Spinal Anesthesia Trays

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
    31491
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0800-05
  • Date de mise en oeuvre de l'événement
    2005-03-28
  • Date de publication de l'événement
    2005-05-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37982
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • Cause
    The anesthesia trays contain bd 25g spinal needles which which have leakage at the plastic hub of the needle.
  • Action
    Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy the needle in the tray and replace it with the replacement needles when the tray is opened prior to the procedure.

Device

Device Recall Baxter Spinal Anesthesia Trays
  • Modèle / numéro de série
    product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333;  product code 1T2450, lot GD809590;  product code 1T2451, lot GD801282;  product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620;  product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335;  product code 2T0188, lot GD812255; product code 2T0298, lot GD809632;  product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699;  product code 2T0458, lot GD811448;  product code 2T0555, lots GD810622, GD809400;  product code 2T0618, lot GD811182;  product code 2T0642, lots GD810655, GD808931;  product code 2T0643, lot GD811455;  product code 2T0661, lots GD808956, GD809434;  product code 2T0770, lot GD810275;  product code 2T0783, lot GD810101;  product code 2T0784, lot GD809830;  product code 2T2001, lot GD810788;  product code 2T2007, lots GD810416, GD812156;  product code 2T2008, lot GD809467;  product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026;  product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127;  product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360;  product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela
  • Description du dispositif
    Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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