CLASS I Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
Part510447 Disposable Infusion Pump recalled by Symbios Medical Products
Symbios Medical Products is recalling Part510447 Disposable Infusion Pump, ...Elastomeric Pump/hr/side,... found in the, distributed nationwide in the US. The recall was initiated on 10 May 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1456-2013
- FDA event ID
- 65192
- Recalling firm
- Symbios Medical Products, Indianapolis, IN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 May 2013
- FDA classified
- 6 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 10 May 2013 | Recall initiated by company | |
| 6 Jun 2013 | Classified by FDA | +27 days |
| 12 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 65192This product is part of a recall event; the main page for the event is Part 510449 Disposable Infusion Pump recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Part 510449 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510636 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510180 Disposable Single Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510490 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510076 Disposable Dual Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510121 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510613 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510613 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510031 Disposable Single Infusion Pump recalled | Symbios Medical Products | Other | Nationwide | |
| CLASS I | Part 510450 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
More recalls from Symbios Medical Products
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Part 510450 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
| Device | CLASS I | Part 510031 Disposable Single Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
| Device | CLASS I | Part 510613 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
| Device | CLASS I | Part 510613 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
| Device | CLASS I | Part 510121 Disposable Infusion Pump recalled | Symbios Medical Products | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |