ICU Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2621-2014)

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:

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.

Product Classification:

Class I

Date Initiated: August 19, 2014

Date Posted: October 1, 2014

Recall Number: Z-2621-2014

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: 100 units

Code Information:

Lot # 2801951

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated