Z-2555-2014Class II

The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and...

Name: Z-2555-2014 The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and...
Creator: Thermedx LLC
Published: 2014-02-10
License: https://open.fda.gov/license/

Thermedx LLC / initiated 2014-02-10 / Terminated / root cause: design

FDA source

Thermedx LLC began a recall of The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the... on 2014-02-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2555-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-10
Posted: 2014-08-27
Terminated: 2015-08-04
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.
Product code: OJR Vacuum Powered Body Fluid Collection Kit
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.
Root cause tag: design
FDA 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 in commerce: 21
Distribution: Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
Product codes and lots: Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2555-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2555-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-27

Product code OJR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)