Official recall record
IV Sets with drip chambers (ref Z-3160-2026)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 20887787005633
- Brand on record
- ICU Medical, Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-15.
Record last checked against the registry on 2026-10-15.
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
Plum administration sets - 2026-05-12 · US FDA — Medical Devices
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical Devices
Oncology sets with drip chambers
All 16 official recall notices naming ICU Medical, Inc. on this site →
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