openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
Distribution pattern
Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
