Recall Z-0996-2013— Smiths Medical ASD, Inc.

Name: FDA recall Z-0996-2013
Creator: U.S. Food and Drug Administration
Published: 2010-05-14

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2010-05-14, terminated 2013-04-11. It names one FDA 510(k) clearance: K040899. 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.. Reason: 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..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2010-05-14
Terminated: 2013-04-11
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPMedex, Inc.·cleared 2004-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.