Events

Rappel de Device Recall Rectal Catheters;

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 Teleflex Medical Europe Ltd.

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
    79579
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1368-2018
  • Date de mise en oeuvre de l'événement
    2018-03-15
  • Date de publication de l'événement
    2018-04-12
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162686
  • 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
    Cystometric gas (carbon-dioxide) on hydraulic device - Product Code FAP
  • Cause
    These products contain latex, but the following statement is not included on any level of product packaging: caution: this product contains natural rubber latex which may cause allergic reactions.
  • Action
    The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have finished collecting and consolidating all of the acknowledgment forms, from your customers and placing a copy of this notification with each unit of affected product in your inventory, please complete the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document completion of this recall. Affected direct customers are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. Users should note This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Upon finding additional lots, the firm issued additional letter on 06/27/2018 with the same message as the letter disseminated in March.

Device

Device Recall Rectal Catheters;
  • Modèle / numéro de série
    Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Rectal Catheters; || Product Code Equivalent Code || 580114 580114 || Product Usage: || Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
  • Manufacturer
    Teleflex Medical Europe Ltd

Manufacturer

Teleflex Medical Europe Ltd
  • Adresse du fabricant
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA