Events

Rappel de Device Recall Simplastic Suprapubic Puncture Instrument

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-1369-2018
  • 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=162687
  • 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
    Catheter, urethral - Product Code GBM
  • 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 Simplastic Suprapubic Puncture Instrument
  • Modèle / numéro de série
    Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45  (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32  (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Simplastic Suprapubic Puncture Instruments: || Product Code Equivalent Code || (a) 650704100 551310 || (b) 650704120 551312 || (c) 650704160 551316 || Product Usage: || RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
  • 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