FDA Device recall Z-1458-2013
Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable…
- FDA Device
- Class I
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class I recall of Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable… 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-1458-2013 |
| 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 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
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 510450, Lot 11-100351- Lot 12-101243 found in: GoBlock Kit 510458, Lot 11-100618 to 13-100703 |
|---|
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-1458-2013%22
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