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FDA (Device enforcement)Recalled 2026-05-12class ii

ICU Medical, Inc.: IV Sets with drip chambers

Is my product affected?

IV Sets with drip chambers

  • UPC 20887787005831

Check against the official notice below — it lists the full affected range.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 86,113 Lot/code info: All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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