Events

Rappel de Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood

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 Becton Dickinson & Co..

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
    64883
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1332-2013
  • Date de mise en oeuvre de l'événement
    2013-03-11
  • Date de publication de l'événement
    2013-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117272
  • 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
    Culture media, non-selective and non-differential - Product Code JSG
  • Cause
    Microbiological media may be contaminated with bacteria.
  • Action
    BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.

Device

Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood
  • Modèle / numéro de série
    Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot 2348108 with expiration date 4/12/13, lot 2348074 with expiration date 4/19/13, and lot 3038371 with expiration date 5/28/13
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.
  • Description du dispositif
    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. || Used for culturing microorganisms.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA