Events

Rappel de Medline Latex Free Labor Kit & Postpartum CDSLF

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 Medline Industries Inc.

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
    49107
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0017-2009
  • Date de mise en oeuvre de l'événement
    2008-08-04
  • Date de publication de l'événement
    2008-10-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73461
  • 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
    Cesarean Section Kit - Product Code OHM
  • Cause
    The latex free labor & delivery packs contain a latex nuk pacifier. the pacifier is packaged separately and offers no risk of exposure of latex particles to other components of the pack.
  • Action
    Recall letters dated 8/4/08 were sent to the direct accounts on the same date, informing them that the labor and delivery packs were labeled Latex Free, but contained a Latex Nuk pacifier. The letters were customized for each account, listing the specific affected reorder numbers and lot numbers shipped to each account. The accounts were requested to immediately check their stocks for the affected lot numbers and quarantine the affected product found. The accounts were given three options: A) Attach the enclosed stickers to the packs so that the user is aware of the latex Nuk pacifier, B) Call Medline to receive replacement non-latex pacifiers, but also place the stickers on the packs, C) Return the packs to Medline for replacements. The accounts were requested to complete the enclosed response form, indicating which option the account selected and whether they needed any additional stickers, and fax the form back to Medline at 847-643-4482 by 8/18/08. Any questions were directed to Kathy Dunne at 1-866-359-1704.

Device

Medline Latex Free Labor Kit & Postpartum CDSLF
  • Modèle / numéro de série
    LABOR KIT & POSTPARTUM CDS-LF reorder # CDS830074D, lots 05HB0427, 05IB0654, 05IB1857, 05KB0229, 06AB1244, 06BB0159, 06CB0593, 06CB1926, 06CB2197, 06FB0015, 06FB0476, 06GB0916, 06HB0704, 06HB2791, 06IB1312, 06IB1922, 06IB2566, 06KB0020, 06KB1042, 06KB2322, 06LB2102, 07AB0437, 07BB2798, 05AD3274, 05BD4131, 05CD3200, 05FD2631;  reorder #CDS830074F, lots 07DB1578, 07GB1509, 07IB0792, 07JB0627, 07JB1829, 07LB0150, 07LB0508, 08BB0151;
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
  • Description du dispositif
    Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA