Z-1459-2013 Class I Terminated
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
- 33, 543 for all kits
Product Description
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery
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
Pump Part 510490, Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491, Lot 11-100601 to 13-100705