Rappel de Device Recall GOPump Elastomeric infusion PumpKit

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • 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
    Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
  • Action
    Symbios sent an Urgent Medical Device Recall letter dated February 25, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to follow the enclosed 'Steps for Voluntary Field Action' in their entirety. These steps contain information about: I) identifying the product to be returned, 2) obtaining a Returned Goods Authorization number, and 3) returning the recalled product. If product(s) is (are) located, please call 317-450-0145 from 7:00 a.In '0 5:00 p.m. EDT to receive a Returned Goods Authorization umber ("RGA"). Please indicate the RGA number on the outside of the package. Attached is a Verification Form. Customers were instructed to complete and return the form even if they do not have any product to return. Their local sales representative can assist them in completing this form. Distributors of the affected product were instructed to contact Symbios at the number provided and forward the recall notice to all their affected accounts. For questions regarding this recall call 317-225-4447.


  • Modèle / numéro de série
    Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125  Kit Part Number 510112-BP, lot 12-101110, 12-101103  Kit: 510401-BP lot 12-101045  Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit  All Kits contain Pump Part Number: 510076 Lot Number: 12-100601
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
  • Description du dispositif
    GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. || The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
  • Manufacturer


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