Reported Apr 3, 2013 · Terminated
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the…
Smiths Medical ASD, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD, Inc. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929
Is this the product you have?
- 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.
- Lot codes and dates
- Lot/Serial Numbers
M76369M76370M76373M76374M76375and M76377
- Lot/Serial Numbers
- Amount recalled
- 6
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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