ICU Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2622-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: August 19, 2014

Date Posted: October 1, 2014

Recall Number: Z-2622-2014

Event ID: 69088

Reason for Recall:

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Status: Terminated

Product Quantity: 1150 units

Code Information:

Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

Distribution Pattern:

Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated