FDA Device recall Z-1455-2013
Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epi…
- FDA Device
- Class I
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class I recall of Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epi… 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-1455-2013 |
| 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
Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 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 | Pump Part 510121, Lot 11-100081 to 12-101406 found in: Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538 GoPump Kit…Pump Part 510121, Lot 11-100081 to 12-101406 found in: Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538 GoPump Kit 510204, Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP, Lot 11-100721 to 13-100680 GoPump Kit 510205BP, Lot 11-100722 to 13-100087 GoBlock kit 510608 |
|---|
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-1455-2013%22
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