Recall Z-2555-2014— Thermedx LLC
Class II · Terminated
Class II FDA medical device recall by Thermedx LLC, initiated 2014-02-10, terminated 2015-08-04. It names 2 FDA 510(k) clearances: K133799, K091939. 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..
- Recalling firm
- Thermedx LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-10
- Terminated
- 2015-08-04
- Firm location
- Solon, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K133799 — THERMEDX FLUID MANAGMENT SYSTEM
- K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.