The Thermedx Fluid Management System is designed to provide… — Class II medical device recall Z-2555-2014
Terminated recall by Thermedx LLC, reported 2014-09-03, distributed nationwide. A vendor changed the manufacturing process of a component used in the canister ring that may affect the perfor
| Recall number | Z-2555-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermedx LLC, Solon, OH, United States |
| Recall initiated | 2014-02-10 |
| Classified | 2014-08-27 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 21 |
| Model numbers | P4000 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2555-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.