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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers 20100001 through 20140044
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Thermedx LLC
- Reason for Recall:
- To correct software bugs that could affect the ability to accurately measure fluid deficit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Serial Numbers 20100001 through 20140044
Distribution:
Distributed in: US, OH, MS, MA, WA, MI, NC, NY, WV, LA, TX, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1463-2015
Related Recalls
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.