FDA Device recall Z-1462-2013
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr
- FDA Device
- Class I
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class I recall of Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr 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-1462-2013 |
| 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 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
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 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233 |
|---|
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-1462-2013%22
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