FDA Medical Device Recalls (openFDA)
Thermedx LLC: 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.
- Recall number
- Z-2555-2014
- Recalling firm
- Thermedx LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-02-10
- Posted
- 2014-08-27
- Terminated
- 2015-08-04
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 21
- Distribution
- Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
- Lot, serial or model codes
- Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
- 510(k) numbers
- ["K091939","K133799"]
- PMA numbers
- not on file
- Product code
- OJR
- Firm FEI
- 3007495879
- Firm city
- Solon
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28