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.
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
These labels are deterministic app interpretations, not FDA categories.
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
Code information
All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;
Distribution pattern
Worldwide Distribution - US Nationwide, VA/govt/military
