Fluid Management System P4000 recall: Software Issue
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit…
Why was Fluid Management System P4000 recalled?
To correct software bugs that could affect the ability to accurately measure fluid deficit.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Serial Numbers 20100001 through 20140044
- Product
- Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit…
- Recalling firm
- Thermedx LLC
- Quantity
- 127 units
- Distribution
- US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
- Recall date
- April 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)