The Recall Desk
HighFDA (Devices)·Z-0699-2021·Announced 2020-12-30

ICU Medical Spiros Administration Sets Recalled for Molding Defect

ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading 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 where injury has not yet been reported, and the potential hazards include exposure to hazardous medications and fluid path contamination.

Plain-English summary

ICU Medical, Inc. is recalling specific Spiros administration sets, extension sets, and related components due to a molding defect. The defect affects the male luer connectors, which may exhibit spinning versions that lead to leaks.

The recall covers 19,850 units distributed worldwide, including nationwide distribution in the United States and in numerous international countries. The affected products include various lengths and configurations of administration and extension sets, as well as specific stopcocks and connectors.

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 source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (2
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
Hazard
Affected units
19,850

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)

  • Lot: 4764635
  • 4887770
  • 4787215
  • 4877053
  • 4737148
  • 4850390
  • 4749863
  • 4849350
  • 4867377
  • 4741238
  • 4763286
  • 4774081
  • 4809085
  • 4877072
  • 4908343
  • 4719787
  • 4734320
  • 4741243
  • 4749867
  • 4854763

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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