Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Sets
Hazard: leakage
contamination
exposure-to-hazardous-medication
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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage