FDANovember 9, 2015device
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
What to do
FDA enforcement status: Terminated
Brands named
c r bard
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 336242026-04-23
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDABD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 788262025-11-06
- FDABard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 7876142025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 7886302025-11-06
- FDASafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,2025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 7884262025-11-06
- FDAVenclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically ...2025-08-21
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