ICU Medical, Inc. recalls REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the pre

Recalled May 19, 2021 · FDA recall Z-1566-2021 · ICU Medical

Hazard

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. · FDA Class II

Sold at

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Description

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Product

REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

Manufacturer(s)

ICU Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →