ICU Medical, Inc.: IV Sets with drip chambers
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ICU Medical, Inc.
- Product
- IV Sets with drip chambers
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-05-12
- Code info
- All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831
- Product quantity
- 86,113
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Clemente
- State
- CA
- Country
- United States
- Event id
- 99058
Free daily digest + "My products" watchlist