FDAFDA · Food and drugs·Recall number Z-1453-2013
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.
Published June 12, 2013 · Recall initiated: May 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Symbios Medical Products, LLC
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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