Agency classClass IIOur severity:High FDA (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.

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 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: fluid-leakage
contamination
air-in-line
exposure-to-hazardous-medications
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 →

Same manufacturer · ICU Medical, Inc.

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