CLASS II Device recall · Reported 3 Sep 2014 · FDA Enforcement Report
Fluid Management System is designed to provide irrigation recalled
Thermedx is recalling The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distributed nationwide in the US. The recall was initiated on 10 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2555-2014
- FDA event ID
- 68986
- Recalling firm
- Thermedx, Solon, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2014
- FDA classified
- 27 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Feb 2014 | Recall initiated by company | |
| 27 Aug 2014 | Classified by FDA | +198 days |
| 3 Sep 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
Where it was distributed
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
Nationwide IllinoisMississippiNew YorkOhioPennsylvaniaVirginiaWashingtonWest Virginia
Questions about this recall
Is Fluid Management System is designed to provide irrigation fluids to irrigate, distend recalled?
Yes. Thermedx recalled Fluid Management System is designed to provide irrigation fluids to irrigate, distend on 10 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-2555-2014.
Why was it 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.
Which lots are affected?
Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
Where was it sold?
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Thermedx
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fluid Management System P4000 recalled by Thermedx | Thermedx | Device Malfunction | 11 states |
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