Events

Rappel de Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.

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 Stryker Instruments Div. of Stryker 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
    56687
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0097-2011
  • Date de mise en oeuvre de l'événement
    2010-08-16
  • Date de publication de l'événement
    2010-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94282
  • 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
    Pump, Infusion - Product Code FRN
  • Cause
    The instructions for use (ifu) has been revised for health care professionals. the indication for use has been changed to remove site specific pain management. the firm has revised the warning to not use the pump around joint spaces. a warning has been added regarding the use of the pump with anticoagulants in epidural applications. a special reminder to users to always evaluate the potential.
  • Action
    Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.

Device

Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stry...
  • Modèle / numéro de série
    09162012, '09163012, '09208012, '09215012, '09223012, '09232012, '09238012, '09246012, '09259012, '09266012, '09280012, '09287012, '09300012, '09303012, '09351012, '09352012, '09353012, '09355022, '09356012, '09362022, '10005012, '10007012, '10008012, '10011012, '10047012, '10048012, '10049012, '10050012, '10074022, '10076012, '10077012, '10078012, '10081022, '10102022, '10103012, '10104012, '10105012, '10106012, '10109022, '10110012, '10111022, '10112032, '10113012, '10116022, '10117012, '10118012, '10119012, '10120012, '10123022, '10124012, '10153012, '10154012 and '10155012.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US, Canada and Australia.
  • Description du dispositif
    Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA