Z-1452-2013 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 in all sizes/ kits
Product Description
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits 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
Pump 510031, Lot 11-l 00106 to Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233 Kit 510350-BP, Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552