—#114372

Product

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K040899
Affected lot / code info: Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.

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.

Root cause (FDA determination)

Device Design

Action the firm took

On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: Distributed in the state of NH.

Timeline

Recall initiated: 2010-05-14
Posted by FDA: 2013-03-26
Terminated: 2013-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.