Recall Z-0076-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-0076-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-16

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-08-16. It names one FDA 510(k) clearance: K040899. Product: Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6. Reason: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-16
Firm location: Minneapolis, 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 Syringe Pump, Model 3500-500, v3, v4, v5, and v6

Reason for recall

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

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