The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0704-2021·Announced 2020-12-30

ICU Medical Recalls Spinning Spiros Syringes and Administration Sets

ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.

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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling specific 3mL, 5mL, 10mL, 20mL, 30mL, and 60mL syringes with spinning Spiros, red cap, as well as various administration sets, extension sets, and oncology kits. The affected products include specific reference numbers such as CH2003, CH2005, CH2010, CH2020, CH2030, CH2060, CH3011, CH3011-C, CH3020, CH3033, CH3034, CH3128, CH3606, CH3625, CH3642, CH3677, CH3700, CH3703, CH3715, CH3929, CH3932, CH3943, CH3944, CH3946, CH3949, and CH4002. The recall covers 534,764 units distributed worldwide, including nationwide distribution in the United States and in numerous international countries.

The recall is due to a potential molding defect in the spinning versions of male luers that may exhibit leaks. This fluid leakage could 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 agency has classified this as a Class II recall.

Healthcare facilities and consumers should stop using the affected products and contact ICU Medical, Inc. for further instructions or a replacement. The specific lot numbers affected are listed in the official recall documentation.

The recalled product

Product
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Sets and Syringes
Hazard
Affected units
534,764

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: 4553702
  • 4605473
  • 4763191
  • 4775520
  • 4849205
  • 4549847
  • 4548779
  • 4572314
  • 4734247
  • 4763917
  • 4849208
  • 4741169
  • 4763921
  • 4560231
  • 4750962
  • 4549850
  • 4763200
  • 4734249
  • 4794307
  • 4806855

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 →

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