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ICU Medical CL3360Recalls & reported problems

Icu Medical, Inc. · 21" Ext Set w/ChemoLock™ Port, Clamp, Graduated Connector · Class 2

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.

59 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 8, 2025Open, Classified

    Port weld of drug transfer device may separate or break during use and potentially result in a leak.

    Z-0351-2026 · Root cause: Under Investigation by firm · 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-3161-2026 · May 12, 2026 · Open, Classified
    IV Sets with drip chambers
  • Z-3159-2026 · May 12, 2026 · Open, Classified
    Oncology 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-0335-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
  • 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-0362-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
  • Z-0353-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
  • Z-0336-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
  • 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-0360-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
  • Z-0350-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Port REF: CL2100
  • Z-0358-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
  • Z-0347-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
  • Z-0344-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
  • Z-0331-2026 · Sep 8, 2025 · Open, Classified
    ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

…and 44 more.

Other Closed antineoplastic and hazardous drug reconstitution and transfer system devices

All Closed antineoplastic and hazardous drug reconstitution and transfer system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.