Device Recall GOPump Elastomeric infusion PumpKit

  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Symbios Medical Products, LLC, 7301 Georgetown Rd., Suite 150, Indianapolis IN 46268
  • Source
    USFDA