Reported Apr 29, 2015 · Terminated
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid…
Thermedx LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thermedx LLC · 31200 Solon Rd · Solon, OH · 44139-3556
Is this the product you have?
- Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.
- Lot codes and dates
- Serial Numbers 20100001 through 20140044
- Amount recalled
- 127 units
Where it was sold
Why it was recalled
To correct software bugs that could affect the ability to accurately measure fluid deficit.
This product could cause temporary or reversible health problems — stop using it.
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