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 4
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Code information
Lot # 2768416
Distribution pattern
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
device · product 2 of 4
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Code information
Lot # 2768417
Distribution pattern
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
device · product 3 of 4
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Code information
Lot # 2801951
Distribution pattern
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
device · product 4 of 4
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
