Recall Z-0610-2020— Smiths Medical ASD Inc.

Name: FDA recall Z-0610-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-28

Class I · Terminated

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2019-10-28, terminated 2024-06-06. It names one FDA 510(k) clearance: K111386. Product: Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.. Reason: There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Terminated
Initiated: 2019-10-28
Terminated: 2024-06-06
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc.·cleared 2011-08-29

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 Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Reason for recall

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

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