FDAFDA · Food and drugs·Recall number Z-0996-2013
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.
Published April 3, 2013 · Recall initiated: May 14, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Distributed in the state of NH.
- Lot
- Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.