FDAFDA · Food and drugs·Recall number Z-1457-2013
Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, 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.
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 Part 510449, Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.