ICU Medical, Inc.: Oncology 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
- Oncology 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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
- 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: 10840619054486, 10887709091914
- Product quantity
- 107,800
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Clemente
- State
- CA
- Country
- United States
- Event id
- 99058
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