FDA-Device2026-09-23Class IIPROCESSING DEFECT
ICU Medical IV tubing sets recalled for black specks in drip chambers
What this means
ICU Medical IV tubing sets with drip chambers may contain black specks caused by discolored plastic material from the manufacturing process. The specks could potentially enter the fluid path during use.
- Check your IV tubing sets for black specks in the drip chamber before use.
- Contact ICU Medical or your healthcare facility if you have affected products.
- Do not use tubing sets with visible black specks or discoloration.
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
6,105,468
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
IV Sets with drip chambers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3161-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical IV gravity administration sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical Plum administration sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical oncology IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical oncology IV tubing sets recalled for black specks in drip chambers
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