Device product
Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 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. The medication is delivered via tubing to the surgical site at a very slow rate
Z-1454-2013
Product summary
- Event
- Event 65192
- Status
- Terminated
- Classification
- Class I
- Quantity
- all kits 33, 543
- Official record key
device-enforcement:Z-1454-2013
Official wording
Reason: 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
Code information: Pump Part 510180, Lot 11-100453 to 12-101003 found in: Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538 Go Pump Kit 510349-BP. Lot 12-100935 Go Pump Kit 510642, Lot 12-100616 to 13-100590
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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