Medfusion Syringe Pump recall
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5…
Why was Medfusion Syringe Pump recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) 0600-00, UDI/DI 10610586041259; b) 0600-01, UDI/DI 10610586041242; c) 0600-50, UDI/DI 10610586043284; d) 0600-51, UDI/DI 10610586043291; e) 0600-82, UDI/DI 10610586043017; f) 0600-249, UDI/DI 10610586041297; All serial numbers
- Product
- Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5…
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 20383 pumps
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)