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ICU Medical CL4164Recalls & reported problems

Icu Medical, Inc. · 75" (191 cm) Appx 9.4 ml, 20 Drop Admin Set w/Integrated ChemoLock? Port Drip Chamber, ChemoLock? Port, ChemoLock? w/Red Cap · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

60 other recalls cover devices cleared under the same FDA submission (K131549); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. May 12, 2026Class IIOpen, Classified

    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.

    Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131549. One submission often covers many models, so check the product and lot details in each record.

  • Z-3159-2026 · May 12, 2026 · Open, Classified
    Oncology sets with drip chambers
  • Z-3161-2026 · May 12, 2026 · Open, Classified
    IV Sets with drip chambers
  • Z-2210-2026 · Mar 24, 2026 · Open, Classified
    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
  • Z-0351-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
  • Z-0332-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
  • Z-0345-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
  • Z-0347-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
  • Z-0365-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
  • Z-0350-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Port REF: CL2100
  • Z-0338-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
  • Z-0354-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
  • Z-0342-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
  • Z-0341-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Bag Spike REF: CL-10
  • Z-0339-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
  • Z-0329-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

…and 45 more.

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Sources and updates

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