Agency classClass IIOur severity:High FDA (Devices)·Z-0706-2021·Announced 2020-12-30

ICU Medical Recalls Spiros Male Luer Devices Due to Molding Defect

ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid 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, which aligns with the High severity criteria for potential harm without confirmed adverse events.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Spiros closed male luer devices, including various administration sets, add-on sets, and connecting lines. The recall is due to a molding defect in the spinning versions of the male luers that may cause leaks.

The potential for fluid leakage may result in several hazards, including 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 distribution in the United States and in numerous international countries.

Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory against the specific lot numbers provided in the official recall notice to identify affected units. No specific instructions for return or replacement are detailed in the provided source text, but standard recall procedures apply.

The recalled product

Product: Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: leakage
contamination
exposure-to-hazardous-medications
air-in-line
Affected units: 217,522

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: 4630846
4848415
4734764
4734940
4752044
4742983
4764957
4878172
4808952
4867502
4804800
4854732
4783273
4773067
4807223
4800168
4877026
4752842
4773432
4764194

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