The Recall Desk
HighFDA (Devices)·Z-0703-2021·Announced 2020-12-30

ICU Medical Recalls ChemoLock Admin Sets Due to Molding Defect

ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II without explicit hospitalization reports, fitting the 'High' criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of ChemoLock administration sets, extension sets, and oncology kits. The recall is due to a molding defect in the spinning versions of male luers, which may exhibit leaks.

Fluid leakage from these defects may potentially cause a delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line. The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries.

Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions. The recall covers specific reference numbers and lot numbers listed in the official FDA notice.

The recalled product

Product
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
Hazard
Affected units
231,250

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lots: 4720479
  • 4724743
  • 4735699
  • 4775051
  • 4803047
  • 4808098
  • 4868079
  • 4868080
  • 4735696
  • 4763384
  • 4800367
  • 4866943
  • 4908482
  • 4724700
  • 4742639
  • 4758414
  • 4775030
  • 4787228
  • 4808060
  • 4848204

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 13 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage

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