Device Recall GOPump

  • Modèle / numéro de série
    Pump 510031, Lot 11-l 00106 to Lot 12-101133  Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233  Kit 510350-BP, Lots12-100429 to 13-100047  Kit 510556-BP Lots 11-100779 to 12-101552
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous || Delivery Time : App. 72 hrs when filled to capacity || Sterile EO... found in the following GoPump Kits: || GoPump Kit 510042, w/ Epidural Catheter || GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH || GoPump Kit 510110, w/2.5" Fenestrated Catheter || GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch || GoPumpKit 510350 w/ Epidural Catheter || GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH || GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH || Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.
  • Manufacturer
  • 1 Event

Fabricant

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

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • 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
    2
  • Dispositif implanté ?
    No
  • 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
  • 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
  • Modèle / numéro de série
    Pump Part 510180, Lot 11-100453 to 12-101003 found in:  Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538  Go Pump Kit 510349-BP. Lot 12-100935 Go Pump Kit 510642, Lot 12-100616 to 13-100590
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; || Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; || Go Pump Kit 510642 || Disposable Single Infusion Pump, 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. The medication is delivered via tubing to the surgical site at a very slow rate
  • Manufacturer
  • Modèle / numéro de série
    Pump Part 510121, Lot 11-100081 to 12-101406 found in:  Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538 GoPump Kit 510204, Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP, Lot 11-100721 to 13-100680  GoPump Kit 510205BP, Lot 11-100722 to 13-100087 GoBlock kit 510608
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits || GoPump Kit 510203-BP, Epidural catheter & BIOPATCH || GoPump Kit 510204, 2.5" Fenestrated catheter || GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch || GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch || GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch || GoBlock kit 510608 || Disposable Single Infusion Pump; 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
  • Modèle / numéro de série
    GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits || GoPump Kit 510462-BP, 5 " catheter & BIOPATCH || GoPump Kit 510558-BP 10 " catheter& BIOPATCH || GoPump Kit 64310 || Disposable Single Infusion Pump. 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
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