Events

Rappel de Boston Scientific Peristaltic Tubing Kit, Model 2104

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 Boston Scientific Corporation.

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
    56909
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0170-2011
  • Date de publication de l'événement
    2010-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94904
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Cause
    Boston scientific is conducting a recall on circucool¿ tubing sets used with the chilli ii¿ cooled ablation system because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. even though there have been no reported complaints.
  • Action
    Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product. If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: _________________ For additional questions call (510) 624-2563.

Device

Boston Scientific Peristaltic Tubing Kit, Model 2104
  • Modèle / numéro de série
    Lot: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan
  • Description du dispositif
    Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA. || Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA