The Thermedx Fluid Management System is designed to provide… recallZ-2555-2014 · Thermedx LLC · initiated Feb 10, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Thermedx LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
Thermedx sent an Urgent Product Correction letter dated March 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were notified that the devices were in need of correction, and that it would be performed at their facilities by Thermedx. Customers with questions were instructed to call a Thermedx technical service representative at 1-888-542-9276. For questions regarding this recall call 440-542-0883.
Recall details
- Recall number
- Z-2555-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 10, 2014
- Posted by the FDA
- Aug 27, 2014
- Recalling firm
- Thermedx LLC
- Quantity
- 21
- Product code
- OJR
- FDA submissions
- K091939, K133799
- Distribution
- Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
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.
Code information (models, lots, serial numbers)
Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
Other devices under the same FDA submission
1 device cleared under K091939, K133799 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fluid Management System P2000Thermedx, LLC · Arthroscope1 death4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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