Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Reported: April 3, 2013 Initiated: May 14, 2010 #Z-0996-2013
Product Description
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Reason for Recall
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 6
- Distribution
- Distributed in the state of NH.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.. Recalled by Smiths Medical ASD, Inc.. Units affected: 6.
Why was this product recalled? ▼
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0996-2013.
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