ICU Medical oncology IV tubing sets recalled for black specks in drip chambers
What this means
ICU Medical oncology IV tubing sets may contain small black specks in the drip chamber. These specks are discolored plastic material from the manufacturing process and do not enter the fluid path. Healthcare providers who notice the specks may replace the set before use, which could delay treatment.
- If you use or dispense these sets, inspect drip chambers for black specks before patient use.
- Contact ICU Medical or your distributor for information on affected lot numbers and replacements.
- Do not delay patient therapy if a set is suspected; use an unaffected replacement immediately.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3158-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical IV tubing 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-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
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