Smiths Medical ASD, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0996-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 14, 2010

Date Posted: April 3, 2013

Recall Number: Z-0996-2013

Event ID: 63621

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.

Status: Terminated

Product Quantity: 6

Code Information:

Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.

Distribution Pattern:

Distributed in the state of NH.

Voluntary or Mandated:

Voluntary: Firm initiated