Medfusion Assembly Plunger Case Left 1/ea recall
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Why was Medfusion Assembly Plunger Case Left 1/ea 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?
Lot Numbers: P0084727, P0104753, P0106429, P0132050, P0166387, P0170765, P0171220, P0181073, P0243080, P0284277
- Product
- Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 118 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)