Z-1460-2013 Class I Terminated
FDA device recall Z-1460-2013 was initiated by Symbios Medical Products, LLC on May 10, 2013 and is designated Class I. 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 comp… The recall status is terminated (terminated March 7, 2014). Affected quantity: 33,543 all kits.
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 all kits
Product Description
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, 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 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475