Z-1462-2013 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
- 33543
Product Description
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
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 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233