Home / Recalls / Symbios Medical Products, LLC / Z-1456-2013

Z-1456-2013 Class I Terminated

Recalled by Symbios Medical Products, LLC — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 12, 2013
Initiation Date
May 10, 2013
Termination Date
March 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34517 for all kits

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

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

Other recalls by Symbios Medical Products, LLC

  • Z-1457-2013 Class I — Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... (May 10, 2013)
  • Z-1459-2013 Class I — Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per s (May 10, 2013)
  • Z-1455-2013 Class I — Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...st (May 10, 2013)
  • Z-1453-2013 Class I — Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 m (May 10, 2013)
  • Z-1458-2013 Class I — Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),.. (May 10, 2013)
  • Z-1461-2013 Class I — Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( (May 10, 2013)
  • Z-1460-2013 Class I — Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( (May 10, 2013)
  • Z-1462-2013 Class I — Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml persi (May 10, 2013)
  • Z-1454-2013 Class I — Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/h (May 10, 2013)
  • Z-1452-2013 Class I — Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME (May 10, 2013)