The Thermedx Fluid Management System is designed to recall
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in…
Why was The Thermedx Fluid Management System is designed to recalled?
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.
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?
Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
- Product
- The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in…
- Recalling firm
- Thermedx LLC
- Quantity
- 21
- Distribution
- Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
- Recall date
- September 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)