Events

Rappel de Centurion

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 Centurion Medical Products 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
    75536
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0647-2017
  • Date de mise en oeuvre de l'événement
    2016-10-21
  • Date de publication de l'événement
    2016-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150739
  • 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,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Cause
    The kits contain multi-med single lumen catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. it is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
  • Action
    Centurion sent an Urgent Recall Notice dated October 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356. For questions regarding this recall call 517-546-5400.

Device

Centurion
  • Modèle / numéro de série
    Centurion Kit Code  ECVC1680  Kit Description SINGLE LUMEN INSERTION BUNDLE Lot Number(s) 2016062150 2016062950 2016070650 Centurion Kit Code ECVC4785  Kit Description SINGLE LUMEN BUNDLE Lot Number(s) 2016081550 Centurion Kit Code M11620HKIC  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016051050  2016053150 2016060750 2016061550 2016063050 2016072050 2016080250 2016091950 Centurion Kit Code M11620HKICNL Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016060750 2016072650 2016093050 2016101050 Centurion Kit Code M11620HS  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016052050 2016062850 2016082350 2016082650 2016090250 Centurion Kit Code M11620KC  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers 2016050950 2016053150 2016060750 2016071250 2016080350 2016082950 Centurion Kit Code M11620KCNL  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)  Lot numbers  2016060850 2016061650 2016062050 2016070550 2016071950 2016080250 2016090750 Centurion Kit Code M12013K  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)  Lot numbers  2016071350 2016072050 2016092650 2016100650 Centurion Kit Code M12013KNL  Kit Description MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)  Lot numbers  2016072950 2016082450
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. || The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Adresse du fabricant
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA