ICU Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2619-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

Product Classification:

Class II

Date Initiated: July 31, 2017

Date Posted: August 15, 2018

Recall Number: Z-2619-2018

Event ID: 80427

Reason for Recall:

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Status: Terminated

Product Quantity: 160,016 units total

Code Information:

Item Number B5216, Lot Number 3335222, 3356780, 3391845, 3401803, 3405384, 3412076, 3416485, 3416486, 3419516, 3429619, 3429620, 3432660

Distribution Pattern:

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated