Events

Rappel de Device Recall Custom Spinal Anesthesia Tray

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 B. Braun Medical, 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
    74879
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0327-2017
  • Date de mise en oeuvre de l'événement
    2016-07-11
  • Date de publication de l'événement
    2016-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148668
  • 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
    Tray, surgical - Product Code LRP
  • Cause
    B. braun medical inc. is voluntarily recalling specific lots of their custom spinal anesthesia tray which contains a drug component, 5% lidocaine hydrochloride and 7.5 % dextrose injection, usp that hospira inc. has recalled because the drug product does not meet the specification for color throughout shelf life.
  • Action
    The firm, B.Braun, mailed to customers a "VOLUNTARY DRUG RECALL NOTIFICATION" letter dated July 12, 2016. The letter described the product, problem and actions to be taken and to inform the customers of a drug recall issued by Hospira, Inc. The Customers were instructed to determine their current inventory of the affected lots Do not destroy any affected product), complete and return "Product Removal Acknowledgement" form via fax to: B.Braun Medical Inc., Quality Assurance department at (610) 849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two weeks of receipt, even if you have no inventory. A BBMI Customer Service Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.

Device

Device Recall Custom Spinal Anesthesia Tray
  • Modèle / numéro de série
    Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: AL, IL, OK, MN, MA and WI.
  • Description du dispositif
    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) || Injection of anesthetics to provide regional anesthesia
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA