Events

Rappel de Device Recall Exodus Standard Loop Multipurpose Drainage Catheter

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 Navilyst 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
    56219
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0015-2011
  • Date de mise en oeuvre de l'événement
    2010-05-24
  • Date de publication de l'événement
    2010-10-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92980
  • 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, biliary, diagnostic - Product Code FGE
  • Cause
    One box containing five catheters did not complete the sterilization process prior to distribution.
  • Action
    On/about 5/24/10, NMI telephoned the consignee. The recall notification package was sent by NMI to the sole consignee on 6/11/10, followed by a telephone call by NMI Quality staff. On 6/15/10, the recall notification package was sent via FedEx to the sole consignee. Subsequently the consignee was provided a return goods authorization (RGA) number for return to NMI. The letter described the product, problem and action to be taken by the consignee/customer. The consignee/customer was instructed to immediately discontinue use of and segregate recalled product; remove the affected lot from their inventory; complete and return the Reply Verification Tracking Form via fax to the QA Manager; Navilyst Medical, Inc., at 1-518-742-4414; to please call the Navilyst Medical Customer Service at 1-800-833-9973 between 8:30 a.m. and 7:00 p.m. (Eastern Standard Time) to obtain a Return Authorization (RGA) Number, and package/ship the recalled product to Navilyst Medical, Inc, Distribution Center, Attn: QA Returns, 10 Glens Falls Technical Park, Glens Falls, NY 12801. If you have any questions, call Navilyst Medical Customer Service at 1-800-833-9973. Subsequent to the initial notification letter, NMI identified that a typo was made to the lot number on the letter. NMI telephoned the consignee and sent a revised letter via fax on 6/25/10 indicating the correct lot number.

Device

Device Recall Exodus Standard Loop Multipurpose Drainage Catheter
  • Modèle / numéro de série
    Lot 1PD0050401
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: Ohio only
  • Description du dispositif
    Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. || Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
  • Manufacturer
    Navilyst Medical, Inc

Manufacturer

Navilyst Medical, Inc
  • Adresse du fabricant
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Société-mère du fabricant (2017)
    Navilyst Medical, Inc
  • Source
    USFDA