Part 510613 Disposable Infusion Pump — Class I medical device recall Z-1461-2013
Terminated recall by Symbios Medical Products, LLC, reported 2013-06-12, distributed nationwide. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the
| Recall number | Z-1461-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Symbios Medical Products, LLC, Indianapolis, IN, United States |
| Recall initiated | 2013-05-10 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-03-07 |
| Distributed | Nationwide (US) |
| Quantity | 33,543 all |
| Lot numbers | 11-100815, 11-100817, 12-10101060, 13-101475 |
| Model numbers | 510613 |
Product
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.