FDA Device recall Z-2555-2014
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to…
- FDA Device
- Class II
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class II recall of The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to… by Thermedx, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2555-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-10 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Thermedx |
| Distribution | US |
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
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.
Identifiers
| code_info | Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2014%22
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