The Recall Desk
HighFDA (Devices)·Z-0711-2021·Announced 2020-12-30

ICU Medical Recalls Spiros Blood Sets Due to Molding Defect

ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.

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 medical device with a defect that poses a risk of harm (contamination, air-in-line, exposure to hazardous substances) but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 2,900 units of the 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795. The recall is due to a molding defect in the male luers that may cause leaks.

The defect could potentially lead to a delay in infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or air-in-line within the fluid path. The affected lots are 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, and 4909635.

The products were distributed nationwide in the United States and internationally to numerous countries including Italy, Belgium, the United Kingdom, Canada, Germany, and others. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement.

The recalled product

Product
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets
Hazard
Affected units
2,900

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 (9)

  • Lots: 4758192
  • 4763891
  • 4794293
  • 4807842
  • 4849283
  • 4866670
  • 4877784
  • 4902534
  • 4909635

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 · fluid leakage

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