Can cause harm that is usually temporary.

IV Sets with drip chambers

Check the device or its packaging for

Why

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Distributed

Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Company

ICU Medical, Inc.

Announced

23 September 2026This is the date the recall was announced. A company may have started it weeks earlier.

Recall began

12 May 2026

Source: FDA record Z-3162-2026 · retrieved 11 September 2026