FDA Device recall Z-1456-2013
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " cath…
- FDA Device
- Class I
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class I recall of Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " cath… by Symbios Medical Products, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1456-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-05-10 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Symbios Medical Products |
| Distribution | US |
Product
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 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.
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
Identifiers
| code_info | GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2013%22
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