Rappel de Device Recall GOPump

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 Symbios Medical Products, LLC.

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
    65192
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1453-2013
  • Date de mise en oeuvre de l'événement
    2013-05-10
  • Date de publication de l'événement
    2013-06-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2014-03-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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, elastomeric - Product Code MEB
  • Cause
    Symbios medical products, indianapolis, indiana, is performing a voluntary recall of all gopumps found in the gopump rapid recovery system kits and all goblock kits manufactured with flow control components assembled prior to july 2012. the recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 ml reservoir, 2 ml/hr gopump (pn510031), and the.
  • Action
    Symbios sent UrgentMedical Device Recall notices to all consignees beginning May 10, 2013. A second corrected/amended notice was sent on May 14, 2013 to consignees and a National Press release was issued. May 30,2013, a third amended Urgent Recall Notice was sent to all consignees correcting the pump description and lot number range table on page 5 of the notice. The notices and press release provided identification of the recalled devices including devices in the previous February 2013 recall, described possible adverse events, and included directions to to quarantine product in a secure location, in preparation for return. Consignees were asked to call 317 225-4447 ext. 25, 8:00 a.m to 4:00 p.m. EDT to receive a Returned Goods Authorization Number prior to returning product. Consignees were asked to complete and return the Attached Verification Form. Question and Concerns should be addressed to 317-225-4447 ext 25.

Device

  • Modèle / numéro de série
    Pump 510076 Lot 11-100222 to 12-101087 found in:  Kit 510080 BP. Lot 11-100215 to 12-100508 Kit 510141-BP Lot 12-100460 to 12-100673  Kit 510112-BP, Lot 11-100839-to 13-100225
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; || GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH || Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH || Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Symbios Medical Products, LLC, 7301 Georgetown Rd., Suite 150, Indianapolis IN 46268
  • Source
    USFDA