ICU Medical, Inc. recalls 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext…

Recall date

July 31, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2646-2018

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 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.