ICU Medical product recalled over sterility concerns

Recall date

February 5, 2018

Source

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

Official notice title

ICU Medical, Inc. recalls 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile…

Recall number

Z-1342-2018

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

Why it was recalled

The infusion sets were manufactured with an incorrect spin collar.

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

What was recalled

6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).