Drug recall
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are…
FDA recall event 65135 · Class I · Medtronic Neuromodulation
Key facts
| Event ID | 65135 |
|---|---|
| Recall numbers | Z-1570-2013, Z-1571-2013 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage…, Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for… |
| Initiation date | Jun 3, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | May 14, 2015 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182207 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: